Aún no reclutaNCT07926737Registro de ClinicalTrials.gov

CMT-133 in Healthy Adult Participants

Healthy Adult Participants

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LO ESENCIAL

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 1
Rango de edad: 18 años - 50 años
Sexo admitido: Todos los sexos
Voluntarios sanos: Aceptados
Participantes: 64 Estimado

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

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CMT-133 in healthy adult participants after single or multiple doses. It is a randomized, double-blind, placebo-controlled, SAD and MAD study, which will be conducted in Parts A and B, respectively. CMT-133 will be administered via SC injection. Placebo will consist of normal saline administered via the same route (SC) and in a manner indistinguishable from active treatment.

¿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:

Body weight ≤110 kg; male participants should be ≥50 kg and female participants should be ≥45 kg.
Body mass index (BMI) between 18.0 kg/m2 and 33.0 kg/m2, inclusive.
In good health as determined by the Investigator (or designee) based on medical history, physical examination, vital signs, electrocardiograms (ECGs), and laboratory assessment, except for findings specifically permitted elsewhere in the inclusion and exclusion criteria, or considered not clinically significant.
Female participants must have negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study.
Female participants must agree not to donate eggs (ova, oocytes) from the time of study drug administration through approximately 330 days after the last dose of study drug.
Male participants with female partners of child-bearing potential must agree to meet one of the following contraception requirements from the time of signing the informed consent form until approximately 300 days after the last dose of study drug: vasectomy, or male condom use plus partner use of highly effective contraceptive methods.
Male participants must agree not to donate sperm from the time of study drug administration through approximately 390 days after the last dose of study drug.

Exclusion Criteria:

Any clinically significant abnormalities in physical examination, vital signs, and laboratory values observed during the Screening visit or Day -1.
History and / or current presence of any clinically significant allergies to any drugs and food.
History and / or current presence of clinically significant cardiovascular, peripheral vascular, or cardiopulmonary disease, including any history of structural heart disease, arrhythmia or conduction disorder.
History of any illness or intervention that, in the opinion of Investigator (or designee), might confound the results of the study or pose an additional risk to the participant by their inclusion in the study.
Current smokers or users of e-cigarettes and nicotine replacement products and those who have used more than 3 of these products per month within the last 6 months prior to Screening; or positive cotinine test at Screening or Day -1; or unable to abstain from smoking (including e-cigarettes and nicotine-containing and non-nicotine-containing vapes) within 48 hours prior to Day -1/check-in until discharge from the study site.
Clinically significant bacterial, viral, fungal, protozoal, or parasitic infection requiring systemic treatment within 4 weeks prior to Screening or between Screening and Day 1.
History of tuberculosis or systemic fungal infectious disease.
Human immunodeficiency virus (HIV) infection or HIV seropositivity at Screening.
Participation in any other clinical research study whilst enrolled in this study; or participation in any other clinical research study evaluating another investigational drug or therapy (including specific immunotherapy) within 30 days or ≥ 5 half-lives, whichever is longer, prior to Screening. Clinical research studies or therapy with biologics are not permitted within 3 months or ≥ 5 half-lives, whichever is longer, prior to Screening.
Pregnant or breastfeeding women.
Unable to comply with study requirements or otherwise believed, by the Investigator (or designee), to be inappropriate for study participation for any reason.

Entiende la evaluación inicial

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 triple

Part A: Single Dose, CMT-133

Participants will receive a single dose of CMT-133 administered on Day 1 at one of the several ascending dose levels with a follow-up period of approximately 300 days.

Biological: CMT-133

Part B: Two doses, CMT-133

Participants will receive 2 doses of CMT-133 administered on Day 1 and Day 15 at one of the several ascending dose levels with a follow-up period of up to 315 days.

Biological: CMT-133

Part A: Single Dose, Placebo

Participants will receive a single dose of Placebo matched to CMT-133 in appearance and administration volume administered on Day 1 with a follow-up period of approximately 300 days.

Drug: Placebo

Part B: Two Doses, Placebo

Participants will receive 2 doses of Placebo administered on Day 1 and Day 15 matched to CMT-133 in appearance and administration volume with a follow-up period of up to 315 days.

Drug: Placebo

CMT-133 BIOLOGICAL

CMT-133 will be administered subcutaneously.

Placebo DRUG

Placebo will be administered subcutaneously.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Safety and Tolerability

Plazo: Up to 315 days

Incidence of treatment-emergent adverse events (TEAEs)