Study of Food Effects of VV261 Tablets in Healthy Trial Participants

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1

Age range

18 years - 45 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

15 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This is a single-center, randomized, open-label, three-cycle, self-cross-over study on human pharmacokinetic characteristics under fasting, standard meal, and high-fat meal conditions.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Aged 18 to 45 years old, males or females;
2. Males weight no less than 50 kg, females weight no less than 45 kg, with body mass index of 19 to 26 kg/m\^2;
3. Vital signs examination, physical examination, laboratory examination ,electrocardiogram examination chest CT and B-ultrasound of liver, gallbladder, pancreas, spleen, kidney and thyroid results are normal or considered abnormal without clinical significance by the investigator;
4. Participants who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;
5. Participants who are able to understand and follow the study protocol and instructions; participants who have voluntarily decided to participate in this study, and sign the informed consent form.

Exclusion Criteria:

1. Participants with hypersensitivity to preparation or any of the excipients;
2. Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
3. Participants with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, hematologic, or metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;participants with a history of gastrointestinal conditions that may impair drug absorption (e.g., gastrectomy or small intestine resection, atrophic gastritis, gastrointestinal ulcers or perforations/fistulas, gastrointestinal bleeding, or obstruction);participants with previous surgery that may significantly affect the body's metabolic process or safety evaluation of the study drug (such as liver, gallbladder, kidney, splenectomy, gastrointestinal resection or excessive blood loss that affects drug absorption, distribution, metabolism)
4. Participants with a history of diseases affecting bone marrow hematopoietic function or reducing immunological function (including leukemia, myelodysplastic syndrome, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis, etc.) or treatment history (tumor chemotherapy or radiotherapy, use of immunosuppressants, etc.);
5. Participants with a history of spleen diseases;
6. If any of the following parameters were considered abnormal with clinical significance: white blood cell count, red blood cell count, platelet count, reticulocyte count, and absolute neutrophil count;
7. If any of the following parameters were considered abnormal with clinical significance: total bilirubin, alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase;
8. Participants who have received blood transfusion or used blood products within 3 months before screening or who have lost more than ≥400 mL of blood due to other reasons (excluding menstruation);
9. Participants who have participated in clinical trials and received drugs within 3 months before screening;
10. Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 2 weeks before screening;
11. Participants who have received vaccination within the first 2 weeks before screening, or planned to receive any vaccine within 1 week after the end of the study;
12. Participants with a history of drug abuse within 1 year before screening or positive urine drug screening within 1 year before screening results (morphine, tetrahydrocannabinol, methamphetamine, dimethylene diphenazine , ketamine, and cocaine);
13. Participants who drink more than 14 standard units or at least twice a day per week within one year before screening,(one standard unit equals 200 mL of beer with 5% alcohol or 25 mL of white wine with 40% alcohol content or 85 mL of red wine with 12% alcohol) or participants with breath alcohol test \>0 mg/100 mL;
14. Participants who smok more than 5 cigarettes a day within one year before screening;
15. Participants who can't quit smoking or drinking during the trial period;
16. Participants who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody (Anti-HIV);
17. Participants who cannot tolerate blood collection with intravenous indwelling needles or blood fainting;
18. Participants with lactose intolerance or cannot comply with a uniform diet (such as special dietary requirements, intolerance of standard meals, etc.), Participants who have consumed excessive amounts of strong tea, coffee or caffeinated beverages in the 3 months before screening;
19. Participants with difficulty in swallowing tablets;
20. Pregnant or lactating women; participants whose spouses or partners intend to become pregnant, plan sperm or oocyte donation within 3 months after the last dose, or decline to use acceptable effective contraception；
21. The investigator believes that there are other unsuitable factors to participate this trial.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Vigonvita Life Sciences

Study start

Nov 9, 2026 Estimated

Primary completion

Dec 30, 2026 Estimated

Study completion

Jan 30, 2027 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts