A Clinical Study of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps.
Sinusitis
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 18 años - 75 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 160 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
To evaluate the effectiveness, safety and pharmacokinetics of TQH2722 injection in patients with chronic sinusitis with or without nasal polyps.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Age 18-75 years old, gender is not limited;
- Bilateral chronic sinusitis (with or without nasal polyps) that meets the diagnostic criteria of The Chinese Guidelines for the Diagnosis and Treatment of Chronic Sinusitis (2018);
- Systemic corticosteroids (at least 1 course of prednisone 0.5 to 1 mg/kg/day or equivalent for at least 5 days) within 2 years prior to the screening, but bilateral chronic sinusitis still exist; and/or patients with drug contraindications/intolerance to systemic glucocorticoids, and (or) patients who have undergone sinus surgery more than 6 months before the screening;
- Before the screening, subjects must have used a stable dose of intranasal corticosteroids (INCS) for more than 4 weeks; For participants who used INCS alternatives rather than Mometasone furoate nasal spray (MFNS) prior to screening, participants should be willing to switch to MFNS in the duration of the study;
- Subjects with asthma started inhaled glucocorticoids at a stable dose at least 4 weeks before the screening and could remain inhaled glucocorticoid doses unchanged throughout the study;
- Patients in the Run-in period should be willing to conduct diary, daily symptom assessment and maintain a stable dose of MFNS with at least 70% adherence;
- Be able to read and understand, and be willing to sign informed consent;
- Participants and their partners agreed to use effective contraception throughout the study period (from the beginning of the screening/run-in period to 3 months after the last dose).
- Part A only：Bilateral nasal polyp score (NPS) assessed by nasal endoscopy ≥5 at both screening and randomization, with a score of ≥2 in each nostril;
- Part A only：Nasal congestion score (NCS) ≥2 at screening (daily score) and at randomization (weekly average score);
- Part A only：The following symptoms have been present continuously for at least 8 weeks prior to screening: ① nasal congestion; ② any other symptom, such as hyposmia/anosmia or rhinorrhea.
- Part B only：Prior to randomization, participants must have bilateral sinus inflammation on CT scan with a total bilateral LMK score ≥8, and bilateral ethmoid sinus opacification.
- Part B only： No nasal polyps confirmed by nasal endoscopy at Visit 1 and at randomization.
- Part B only：Subjects must have had persistent hyposmia for at least 4 consecutive weeks prior to Visit 1.
- Part B only：At screening, subjects have moderate or severe smell loss (smell loss score ≥2), and the weekly average severity ≥2 at randomization.
- Part B only：Subjects must have a sTSS (nasal congestion \[NC\], rhinorrhea, facial pain/pressure) ≥2 at screening (daily score) and at randomization (weekly average score).
- Part B only：Participants who have had at least one blood routine test within 2 years prior to screening, or at screening, showing blood eosinophils meeting any of the following criteria:
1. Blood eosinophil count ≥0.25×10⁹/L;
2. Blood eosinophil percentage ≥6.9% and the subject does not have asthma;
3. Blood eosinophil percentage ≥3.7% and the subject has asthma.
Exclusion Criteria:
- Any of the following laboratory abnormalities present at screening or randomization:
1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 × upper limit of normal (ULN);
2. Total bilirubin \>2 × ULN (except for indirect bilirubin elevation secondary to Gilbert's syndrome);
3. Creatinine \>1.5 × ULN;
* Any disease that the investigator considers unstable and may affect the patient's safety throughout the study period, or affect or interpretation with the results, or interfere with the patient's ability to complete the entire research process, including but not limited to cardiovascular, gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic diseases, psychiatric disorders, or major limb disorders. For example, but not limited to: ischemic heart disease, left ventricular failure, arrhythmia, uncontrolled hypertension, uncontrolled hyperglycemia, cerebrovascular disease, etc.;
* Patients with active autoimmune disease（including, but not limited to, Hashimoto's thyroiditis, Graves' disease, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis and other neuroinflammatory diseases, psoriasis vulgaris, and rheumatoid arthritis）;
* Known or suspected immunosuppression, including but not limited to a history of invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved;
* Subjects with active malignant tumors or a history of malignant tumors; Patients with basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix may be enrolled in this study if at least 12 months have elapsed since the completion of curative treatment prior to Visit 1; patients with other malignant tumors may be enrolled in this study if at least 5 years have elapsed since the completion of curative treatment prior to Visit 1;
* History of active pulmonary tuberculosis within the 12 months before screening;
* Active hepatitis during the screening period, or positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) and positive hepatitis B virus (HBV) DNA, or positive hepatitis C virus (HCV) antibody and positive HCV-RNA; or positive for antibodies to human immunodeficiency virus (Anti-HIV) or positive for treponemal antibodies (Anti-TP);
* Diagnosed with helminth parasitic infection within 6 months before the screening period, did not receive standard treatment or the standard treatment was ineffective;
* Subjects who have received any of the following treatments:
1. Sinus surgery or sinonasal surgery within 6 months prior to screening (Visit 1);
2. Treatment with monoclonal antibodies within 8 weeks or 5 half-lives prior to screening, whichever is longer, including but not limited to benralizumab, mepolizumab, omalizumab, reslizumab, dupilumab, and other drugs of the same class (IL-4R inhibitors), etc;
3. Treatment with immunosuppressive agents within 8 weeks or 5 half-lives prior to screening, whichever is longer, including but not limited to cyclophosphamide, cyclosporine, interferon-γ, azathioprine, methotrexate, mycophenolate mofetil, and tacrolimus, etc;
4. Use of other non-biologic investigational drugs within 8 weeks or 5 half-lives prior to screening, whichever is longer;
5. Intravenous immunoglobulin (IVIG) therapy and/or plasmapheresis within 30 days prior to the screening visit (Visit 1);
6. Subjects who received leukotriene antagonists/modifiers within 4 weeks prior to randomization (subjects on a stable dose of leukotriene modifiers for ≥30 consecutive days prior to randomization may be enrolled);
7. Initiated allergen immunotherapy within 3 months prior to screening, or planned to initiate such treatment during the study period or to change the treatment dose during the study;
8. Receipt of live attenuated vaccines within 4 weeks prior to screening, or planned receipt of live attenuated vaccines during the study period;
9. Use of systemic corticosteroids within 4 weeks prior to screening;
10. Within 2 weeks prior to screening or during the screening/run-in period, had a chronic active or acute infection requiring systemic treatment with antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungal agents;
* Patients with combined asthma should be excluded if they have:
1. Forced expiratory volume in the first second (FEV1) ≤ 50% of normal estimates;
2. Acute exacerbation of asthma within 90 days prior to screening, requiring hospitalization (\>24 hours);
3. used daily doses higher than 1000 mcg of fluticasone or equivalent inhaled corticosteroids (ICS);
* The subject had concomitant diseases that prevented him/her from completing the screening period assessment or from evaluating the primary efficacy endpoint:
1. Deviation of the nasal septum causing complete obstruction of at least one nostril;
2. Acute sinusitis, nasal infection, or upper respiratory tract infection at screening or within 2 weeks prior to screening;
3. Persistent rhinitis medicamentosa;
4. Diagnosed with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other ciliary dyskinesia syndromes, or cystic fibrosis;
5. Radiologically suspected or confirmed fungal rhinosinusitis;
* Subjects with nasal malignancies and benign tumors (e.g., papillomas, hemangiomas, etc.);
* Subjects who are unable to use MFNS or who are allergic or intolerant to mometasone furoate nasal spray;
* Subjects with a history of anaphylaxis to any biological agent (other than local injection site reactions);
* Pregnant or lactating women;
* Alcoholism, drug addiction and known drug dependence;
* Have participated in clinical trials of other medical devices within 12 weeks before screening;
* The subject had poor compliance in the research and could not complete the study as judged by the investigator;
* In the judgment of the investigator or sponsoring medical reviewer, it is believed that there are any medical or psychiatric symptoms that put the subject at risk, interfere with participation in the study, or interfere with the interpretation of the results of the study.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento cuádruple
300mg of TQH2722 injection
TQH2722 injection, 14 days as a treatment cycle.
Drug: 300mg of TQH2722 injection
600mg of TQH2722 injection
TQH2722 injection, 14 days as a treatment cycle.
Drug: 600mg of TQH2722 injection
TQH2722 injection matching placebo
TQH2722 injection matching placebo, 14 days as a treatment cycle.
Drug: TQH2722 injection matching placebo
300mg of TQH2722 injection DRUG
TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
600mg of TQH2722 injection DRUG
TQH2722 injection is a fully human monoclonal antibody that interfering with the signal cascade.
TQH2722 injection matching placebo DRUG
Placebo without active substance.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Changes in the nasal polyp score of subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) from baseline at week 16 in part A
Plazo: Up to 16 weeks.
Changes in nasal polyp score from baseline in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) at week 16 in part A. The total score is 0-8 points, with the higher score meaning the more severe symptoms.
Changes in the Lund-Mackay score of sinus CT scans of subjects with chronic rhinosinusitis without nasal polyps (CRSsNP) from baseline at week 16 in part B
Plazo: Up to 16 weeks.
Changes in Lund-Mackay score on sinus CT scan from baseline in subjects with chronic rhinosinusitis without nasal polyps (CRSsNP) at week 16 in part B. The total score is 0-24 points, with the higher score meaning the more severe symptoms.
Medidas secundarias
Changes in Lund-Mackay scores of CT scans of subjects from baseline at week 16 in Part A
Plazo: Up to 16 weeks.
Changes in Lund-Mackay scores of CT scans of subjects from baseline at week 16 in Part A. The total score is 0-24 points, with the higher score meaning the more severe symptoms.
Changes in the subjects' modified Lund-Kennedy endoscopic scores from baseline at week 16 in Part A
Plazo: Up to 16 weeks.
Changes in the subjects' modified Lund-Kennedy endoscopic scores from baseline at week 16 in Part A. The total score is 0-12 points, with the higher score meaning the more severe symptoms.
Changes in the subjects' sinus total symptom score (sTSS) from baseline at week 16 in Part A
Plazo: Up to 16 weeks.
Changes in the subjects' sinus total symptom score (sTSS) from baseline at week 16 in Part A. The total score is 0-9 points, with the higher score meaning the more severe symptoms.
Changes in the 22-item Sino-Nasal Outcome Test (SNOT-22) from baseline at week 16 in Part A
Plazo: Up to 16 weeks.
Changes in the 22-item Sino-Nasal Outcome Test (SNOT-22) from baseline at week 16 in Part A. The total score is 0-110 points, with the higher score meaning the more severe symptoms.
Changes in the University of Pennsylvania Smell Identification Test (UPSIT) from baseline at week 16 in Part A.
Plazo: Up to 16 weeks.
Changes in the University of Pennsylvania Smell Identification Test (UPSIT) from baseline at week 16 in Part A. The total score is 0-40 points, with the lower score meaning the more severe symptoms.
Changes in loss-of-smell score of the subjects from baseline at week 16 in Part A
Plazo: Up to 16 weeks.
Changes in loss-of-smell score of the subjects from baseline at week 16 in Part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Changes in nasal congestion score (NCS) of subjects from baseline at week 16in Part A
Plazo: Up to 16 weeks.
Changes in nasal congestion score (NCS) of subjects from baseline at week 16 in Part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Changes in nasal discharge/post-nasal drip score of the subjects from baseline at week 16 in Part A
Plazo: Up to 16 weeks.
Changes in nasal discharge/post-nasal drip score of the subjects from baseline at week 16in Part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Changes in facial pain/pressure score of the subjects from baseline at week 16 in Part A
Plazo: Up to 16 weeks.
Changes in facial pain/pressure score of the subjects from baseline at week 16 in Part A. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Changes in the visual analogue scale (VAS) score of the subjects from baseline at week 16in Part A
Plazo: Up to 16 weeks.
Changes in the visual analogue scale (VAS) score of the subjects from baseline at week 16 in Part A. The total score is 0-10 points, with the higher score meaning the more severe symptoms.
Changes in health-related quality of life (HRQoL) at Week 16 of the subjects from baseline at week 16 in Part A
Plazo: Up to 16 weeks.
Changes in health-related quality of life (HRQoL) at Week 16 of the subjects from baseline at week 16 in Part A. The Health survey short form (SF-36) total score is 0-100 points, with the higher score meaning the higher quality of life.
Changes in peak nasal inspiratory flow rate (NPIF) of the subjects from baseline at week 16 in Part A
Plazo: Up to 16 weeks.
Changes in peak nasal inspiratory flow rate (NPIF) of the subjects from baseline at week 16 in Part A
Proportion of subjects who received systemic corticosteroids (SCS) rescue therapy or surgical treatment during the 16-week treatment period in Part A
Plazo: Up to 16 weeks.
Proportion of subjects who received systemic corticosteroids (SCS) rescue therapy or surgical treatment during the 16-week treatment period s in Part A.
Incidence of adverse events in Part A
Plazo: Up to 24 weeks.
Incidence of adverse events (AES) and serious adverse events (SAEs), as well as abnormal laboratory test indicators in Part A
Severity of adverse events in Part A
Plazo: Up to 24 weeks.
Severity of adverse events (AES) and serious adverse events (SAEs), as well as abnormal laboratory test indicators in Part A
peak plasma concentration (Cmax)in Part A
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Maximum plasma drug concentration in Part A
Trough concentration (Cmin) in Part A
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Minimum plasma drug concentration in Part A
Time to peak concentration (Tmax)in Part A
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The time required to reach peak concentration after administration in Part A
Area under the plasma concentration-time curve (AUC0-t)in Part A
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The area enclosed by the plasma concentration curve to the timeline in Part A.
Steady-state peak concentration (Css-max) in Part A
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The highest plasma concentration that occurs in steady state in Part A.
Steady-state valley concentration (Css-min) in Part A
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The lowest plasma concentration that occurs in steady state in Part A.
Average steady-state plasma concentration (Css-av) in Part A
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The quotient obtained by dividing the area under the plasma concentration-time curve by the interval time τ during a dose interval when the blood concentration reaches a steady state in Part A.
Steady-state time to peak concentration (Tss-max) in Part A
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The time required to reach peak steady-state concentration after administration in Part A
Steady-state area under the plasma concentration-time curve (AUCss,0-t) in Part A
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Area under the plasma concentration-time curve in steady state in Part A.
Half-life (t1/2) in Part A
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The time it takes for half the drug to be eliminated from the body in Part A
Apparent volume of distribution (Vd/F) in Part A
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The ratio of the amount of drug in the body to the concentration in the blood after the drug has reached homeostasis in the body in Part A
Clearance (CL/F) in Part A
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Per unit time, the volume of drug-containing liquid is completely and effectively removed by the elimination organ in Part A
Anti-drug antibody (ADA) positive rate of subjects in Part A
Plazo: Within 1 hour before the first dose; 336 hours after the last dose; 168 days after the first dose.
Anti-drug antibody (ADA) positive rate of subjects in Part A
Titer of Anti-drug antibody (ADA) of subjects in Part A
Plazo: Within 1 hour before the first dose; 336 hours after the last dose; 168 days after the first dose.
Titer of Anti-drug antibody (ADA) of subjects in Part A
Incidence of subjects with neutralizing antibodies (Nab) in Part A
Plazo: Within 1 hour before the first dose; 336 hours after the last dose; 168 days after the first dose.
Incidence of subjects with neutralizing antibodies (Nab) in Part A.
Changes in the University of Pennsylvania Smell Identification Test (UPSIT) from baseline at week 16in Part B
Plazo: Up to 16 weeks.
Changes in the University of Pennsylvania Smell Identification Test (UPSIT) from baseline at week 16 in Part B. The total score is 0-40 points, with the lower score meaning the more severe symptoms.
Changes in loss-of-smell score of the subjects from baseline at week 16 in Part B
Plazo: Up to 16 weeks.
Changes in loss-of-smell score of the subjects from baseline at week 16 in Part B. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Changes in the subjects' modified Lund-Kennedy endoscopic scores from baseline at week 16 in Part B
Plazo: Up to 16 weeks.
Changes in the subjects' modified Lund-Kennedy endoscopic scores from baseline at week 16 in Part B. The total score is 0-12 points, with the higher score meaning the more severe symptoms.
Changes in the subjects' sinus total symptom score (sTSS) from baseline at week 16 in Part B
Plazo: Up to 16 weeks.
Changes in the subjects' sinus total symptom score (sTSS) from baseline at week 16 in Part B. The total score is 0-9 points, with the higher score meaning the more severe symptoms.
Changes in the 22-item Sino-Nasal Outcome Test (SNOT-22) from baseline at week 16 in Part B
Plazo: Up to 16 weeks.
Changes in the 22-item Sino-Nasal Outcome Test (SNOT-22) from baseline at week 16 in Part B. The total score is 0-110 points, with the higher score meaning the more severe symptoms.
Changes in nasal discharge/postnasal drip score of the subjects from baseline at week 16 in Part B
Plazo: Up to 16 weeks.
Changes in nasal discharge/postnasal drip score of the subjects from baseline at week 16 in Part B. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Changes in facial pain/pressure score of the subjects from baseline at week 16 in Part B
Plazo: Up to 16 weeks.
Changes in facial pain/pressure score of the subjects from baseline at week 16 in Part B. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Changes in the visual analogue scale (VAS) of the subjects from baseline at week 16s in Part B
Plazo: Up to 16 weeks.
Changes in the visual analogue scale (VAS) of the subjects from baseline at week 16 in Part B. The total score is 0-10 points, with the higher score meaning the more severe symptoms.
Proportion of subjects who received systemic corticosteroids (SCS) rescue therapy or surgical treatment during the 16-week treatment period in Part B
Plazo: Up to 16 weeks.
Proportion of subjects who received systemic corticosteroids (SCS) rescue therapy or surgical treatment during the 16-week treatment period in Part B.
Incidence of adverse events in Part B
Plazo: Up to 24 weeks.
Incidence of adverse events (AES) and serious adverse events (SAEs), as well as abnormal laboratory test indicators in Part B.
Severity of adverse events in Part B
Plazo: Up to 24 weeks.
Severity of adverse events (AES) and serious adverse events (SAEs), as well as abnormal laboratory test indicators in Part B.
Peak plasma concentration in Part B
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Maximum plasma drug concentration in Part B.
Trough concentration (Cmin) in Part B
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Minimum plasma drug concentration in Part B.
Time to peak concentration (Tmax) in Part B
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The time required to reach peak concentration after administration in Part B.
Area under the plasma concentration-time curve (AUC0-t)in Part B
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The area enclosed by the plasma concentration curve to the timeline in Part B.
Steady-state peak concentration (Css-max) in Part B
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The highest plasma concentration that occurs in steady state in Part B.
Steady-state trough concentration (Css-min) in Part B
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The lowest blood concentration that occurs in steady state in Part B.
Average steady-state plasma concentration (Css-av) in Part B
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The quotient obtained by dividing the area under the blood concentration-time curve by the interval time τ during a dose interval when the blood concentration reaches a steady state in Part B.
Steady-state time to peak concentration (Tss-max) in Part B
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The time required to reach peak steady-state concentration after administration in Part B.
Steady-state area under the plasma concentration-time curve (AUC ss,0-t) in Part B
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Area under the plasma concentration-time curve in steady state in Part B.
half-life in Part B
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The time it takes for half the drug to be eliminated from the body in Part B.
Apparent volume of distribution (Vd/F) in Part B
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
The ratio of the amount of drug in the body to the concentration in the blood after the drug has reached homeostasis in the body in Part B.
Clearance (CL/F) in Part B
Plazo: Within 1 hour before and 1, 4, 8, 12, 24, 72, 168 hours after the first dose; Within 1 hour before the 2nd, 3rd, and 6th doses; Within 1 hour before and 1, 4, 8, 12, 24, 48, 72, 168, 336, 672, 840 hours after the last dose.
Per unit time, the volume of drug-containing liquid is completely and effectively removed by the elimination organ in Part B.
Anti-drug antibody (ADA) positive rate of subjects in Part B
Plazo: Within 1 hour before the first dose; 336 hours after the last dose; 168 days after the first dose.
Anti-drug antibody (ADA) positive rate of subjects in Part B.
Titer of Anti-drug antibody (ADA) of subjects in Part B
Plazo: Within 1 hour before the first dose; 336 hours after the last dose; 168 days after the first dose.
Titer of Anti-drug antibody (ADA) of subjects in Part B.
Incidence of subjects with neutralizing antibodies (Nab) in Part B
Plazo: Within 1 hour before the first dose; 336 hours after the last dose; 168 days after the first dose.
Incidence of subjects with neutralizing antibodies (Nab) in Part B.
Changes in Asthma Control Questionnaire (ACQ-6) score from baseline among subjects with combined asthma in part A
Plazo: Up to 16 weeks.
Change in ACQ-6 score from baseline among subjects with combined asthma in part A. The total score ranges from 0 to 6, with higher scores indicating less well-controlled asthma
Change of total Immunoglobulin E (IgE) in peripheral blood from baseline in Part A
Plazo: Up to 16 weeks.
Change of total Immunoglobulin E (IgE) in peripheral blood from baseline in subjects at Week 16 in Part A.
Change of Eosinophil count in peripheral blood from baseline in Part A
Plazo: Up to 16 weeks.
Change of Eosinophil count in peripheral blood from baseline in subjects in Part A.
Change from baseline in peripheral blood eotaxin-3 (CCL26) concentrations in subjects in Part A
Plazo: Up to 16 weeks.
Change from baseline in peripheral blood eotaxin-3 (CCL26) concentrations in subjects at Week 16 in Part A.
Change from baseline in peripheral blood Cystatin-SN (CST1) in subjects in part A
Plazo: Up to 16 weeks
Change from baseline in peripheral blood Cystatin-SN (CST1) in subjects at Week 16 in part A.
Change from baseline in Cystatin-SN (CST1) in nasal exfoliated cells in Part A
Plazo: Up to 16 weeks
Change from baseline in Cystatin-SN (CST1) in nasal exfoliated cells in subjects at Week 16 in Part A.
Change from baseline in eotaxin-3 (CCL26) in nasal exfoliated cells in Part A
Plazo: Up to 16 weeks
Change from baseline in eotaxin-3 (CCL26) in nasal exfoliated cells in subjects at Week 16 in Part A
Change from baseline in Charcot-Leyden crystal protein (CLC) in nasal exfoliated cells in Part A
Plazo: Up to 16 weeks.
Change from baseline in Charcot-Leyden crystal protein (CLC) in nasal exfoliated cells in Part A.
Change from baseline inArachidonate 15-lipoxygenase (ALOX15) in nasal exfoliated cells in Part A
Plazo: Up to 16 weeks.
Change from baseline in Arachidonate 15-lipoxygenase (ALOX15) in nasal exfoliated cells in subjects at Week 16 in Part A
Change from baseline in cytokines in nasal secretions of Part A
Plazo: Up to 16 weeks
Changes in cytokines in nasal secretions from baseline at week 16 of Part A.
Changes in microorganisms in nasal secretions from baseline at week 16 of Part A
Plazo: Up to 16 weeks.
Change from baseline in microbiota in nasal secretions in subjects at Week 16 of Part A.
Changes in nasal congestion score (NCS) from baseline at week 16 in Part B
Plazo: Up to 16 weeks.
Change in subjects' Nasal congestion Score (NCS) from baseline at week 16 in Part B. The total score is 0-3 points, with the higher score meaning the more severe symptoms.
Changes in ACQ-6 scores in subjects with asthma from baseline at week 16 in part B
Plazo: Up to 16 weeks.
Change in ACQ-6 score from baseline among subjects with combined asthma in part B. The total score ranges from 0 to 6, with higher scores indicating less well-controlled asthma.
Change of total Immunoglobulin E (IgE) in peripheral blood from baseline in Part B
Plazo: Up to 16 weeks
Change of total Immunoglobulin E (IgE) in peripheral blood from baseline in subjects at Week 16 in Part B.
Change of Eosinophil count in peripheral blood from baseline in Part B
Plazo: Up to 16 weeks
Change of Eosinophil count in peripheral blood from baseline in subjects in Part A
Change from baseline in peripheral blood eotaxin-3 (CCL26) concentrations in subjects in Part B
Plazo: Up to 16 weeks.
Change from baseline in peripheral blood eotaxin-3 (CCL26) concentrations in subjects at Week 16 in Part B
Change from baseline in Cystatin-SN (CST1) in subjects in part B
Plazo: Up to 16 weeks.
Change from baseline in Cystatin-SN (CST1) in subjects at Week 16 in part B
Change from baseline in Cystatin-SN (CST1) in nasal exfoliated cells in Part B
Plazo: Up to 16 weeks.
Change from baseline in Cystatin-SN (CST1) in nasal exfoliated cells in subjects at Week 16 in Part B.
Change from baseline in eotaxin-3 (CCL26) in nasal exfoliated cells in Part B
Plazo: Up to 16 weeks.
Change from baseline in eotaxin-3 (CCL26) in nasal exfoliated cells in subjects at Week 16 in Part B.
Change from baseline in Charcot-Leyden crystal protein (CLC) in nasal exfoliated cells in Part B
Plazo: Up to 16 weeks.
Change from baseline in Charcot-Leyden crystal protein (CLC) in nasal exfoliated cells in subjects at Week 16 in Part B.
Change from baseline inArachidonate 15-lipoxygenase (ALOX15) in nasal exfoliated cells in Part B
Plazo: Up to 16 weeks.
Change from baseline in Arachidonate 15-lipoxygenase (ALOX15) in nasal exfoliated cells in subjects at Week 16 in Part B.
Change from baseline in cytokines in nasal secretions of Part B
Plazo: Up to 16 weeks.
Changes in cytokines in nasal secretions from baseline at week 16 of Part B.
Change from baseline in microbiota in nasal secretions of Part B
Plazo: Up to 16 weeks.
Changes in microorganisms in nasal secretions from baseline at week 16 of Part B.
Changes in health-related quality of life (HRQoL) at Week 16 of the subjects from baseline at week 16 in Part B
Plazo: Up to 16 weeks.
Changes in health-related quality of life (HRQoL) at Week 16 of the subjects from baseline at week 16 in Part B. The Health survey short form (SF-36) total score is 0-100 points, with the higher score meaning the higher quality of life.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (36)
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36 centros
The First Affiliated Hospital of Wannan Medical CollegeWuhu, Anhui, ChinaEstado desconocido
Beijing HospitalBeijing, Beijing Municipality, ChinaEstado desconocido
Beijing TongRen Hospital, Capital Medical UniversityBeijing, Beijing Municipality, ChinaEstado desconocido
Lanzhou University Second HospitalLanzhou, Gansu, ChinaEstado desconocido
Foshan First People's HospitalFoshan, Guangdong, ChinaEstado desconocido
Jieyang People's HospitalJieyang, Guangdong, ChinaEstado desconocido
The Second People's Hospital of ShenzhenShenzhen, Guangdong, ChinaEstado desconocido
The People's Hospital of Guangxi Zhuang Autonomous RegionNanning, Guangxi, ChinaEstado desconocido
The Affiliated hospital of Guizhou Medical UniversityGuiyang, Guizhou, ChinaEstado desconocido
Cangzhou Central HospitalCangzhou, Hebei, ChinaEstado desconocido
Hebei Medical University Third HospitalShijiazhuang, Hebei, ChinaEstado desconocido
Henan Provincial People's HospitalZhengzhou, Henan, ChinaEstado desconocido
Union Hospitalc, Tongji Medical College, Huazhong, University of Science and TechnologyWuhan, Hubei, ChinaEstado desconocido
Renmin Hospital of Wuhan UniversityWuhan, Hubei, ChinaEstado desconocido
Loudi Central HospitalChangsha, Hunan, ChinaEstado desconocido
Baotou Central HospitalBaotou, Inner Mongolia, ChinaEstado desconocido
The Affiliated Hospital of Inner Mongolia Medical UniversityHohhot, Inner Mongolia, ChinaEstado desconocido
Nanjing Drum Tower HospitalNanjing, Jiangsu, ChinaEstado desconocido
The First Affiliated Hospital of Soochow UniversitySuzhou, Jiangsu, ChinaEstado desconocido
Jilin Province People's HospitalChangchun, Jilin, ChinaEstado desconocido
The Affiliated Hospital of Yanbian UniversityYanji, Jilin, ChinaEstado desconocido
The First Hospital of China Medical UniversityShenyang, Liaoning, ChinaEstado desconocido
Shengjing Hospital of China Medical UniversityShenyang, Liaoning, ChinaEstado desconocido
Central Hospital of Shenyang Medical CollegeShenyang, Liaoning, ChinaEstado desconocido
Shandong Second People's HospitalJinan, Shandong, ChinaEstado desconocido
Weifang Second People's HospitalWeifang, Shandong, ChinaEstado desconocido
Weihai Central HospitalWeihai, Shandong, ChinaEstado desconocido
Yantai Yuhuangding HospitalYantai, Shandong, ChinaEstado desconocido
Zibo Central HospitalZibo, Shandong, ChinaEstado desconocido
Renji Hospital Affiliated to Shanghai Jiaotong University School of MedicineShanghai, Shanghai Municipality, ChinaEstado desconocido
First Hospital of Shanxi Medical UniversityTaiyuan, Shanxi, ChinaEstado desconocido
Chengdu Second People's HospitalChengdu, Sichuan, ChinaEstado desconocido
Sichuan Provincial People's HospitalChengdu, Sichuan, ChinaEstado desconocido
The First Affiliated Hospital of Xinjiang Medical UniversityÜrümqi, Xinjiang, ChinaEstado desconocido
Wenling First People's HospitalTaizhou, Zhejiang, ChinaEstado desconocido
Taizhou central hospitalTaizhou, Zhejiang, ChinaEstado desconocido
Equipo y fechas
- Patrocinador principal
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Inicio del estudio
- 28 dic 2023 Real
- Finalización primaria
- 30 mar 2025 Real
- Finalización del estudio
- 30 abr 2025 Real
- Primera publicación
- 18 oct 2023 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trials to Assess the Effectiveness, Safety and Pharmacokinetics of TQH2722 Injection in Patients With Chronic Sinusitis With or Without Nasal Polyps.
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026