Safety and dosing of VV913 capsules in healthy adults
Official title: Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV913 Capsules in Chinese Healthy Participants
Run by Vigonvita Life Sciences · NCT07507838 · Data updated 2026-11-12
This study tests different doses of VV913 to see if it is safe and how it behaves in the body for healthy adult men in China.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | Men only |
| Enrollment | 24 (estimated) |
| Sponsor | Vigonvita Life Sciences Industry-sponsored |
| Locations | 1 site (Hefei, Anhui) |
| Status | Recruiting |
| Started | April 13, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT07507838 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adult men aged 18 to 45 years, with normal or clinically insignificant health assessments, who can use effective contraception during the study.
✕Probably not a fit
Healthy volunteers who do not meet the health or age criteria or who experience adverse reactions that preclude participation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation study in Chinese healthy adult men. Participants receive VV913 at 4 mg, 8 mg, or 15 mg or placebo across multiple rising dose cohorts to evaluate safety, tolerability, and pharmacokinetics after multiple administrations. The trial aims to characterize how the drug is absorbed, distributed, metabolized, and eliminated, and to identify any dose-related safety signals. Enrollment targets healthy volunteers meeting specific age, weight, and health criteria, with careful monitoring throughout the study. The study is led by Vigonvita Life Sciences in collaboration with The First Affiliated Hospital of Anhui Medical University.
Why it matters
Potential benefit: If successful, participants may contribute to determining safe dosing for VV913 in future research.
How similar studies have gone: Early-phase dose-escalation PK/safety studies are common first steps in drug development; this study follows established approaches in healthy volunteers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 to 45 years old, males ; 2. Males weight no less than 50 kg, with body mass index of 19 to 26 kg/m\^2; 3. Vital signs examination, physical examination, laboratory examination ,Chest X-ray 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); 4. Participants with a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial; 5. Participants with a blood donation or blood loss ≥ 400 mL within 3 months before screening, or a history of blood product use within 3 months before screening; 6. Participating in any clinical trial and taking clinical trial drugs within 90 days before screening; 7. Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before screening; 8. Participants who have received vaccination within 14 days before screening, or planned to receive any vaccine during the trial or within 1 week after the end of the study; 9. 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); 10. 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 spirits with 40% alcohol content or 85 mL of wine with 12% alcohol content); 11. Participants who smoke more than 5 cigarettes a day within one year before screening; 12. Participants who can't quit smoking or drinking during the trial period; 13. Participants who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody (Anti-HIV); 14. Having special requirements for food, unable to observe a unified diet or having dysphagia; 15. Participants who cannot avoid consuming drinks containing xanthine (such as coffee and tea) or foods (such as chocolate and animal liver), or fruits or juices (such as grapefruit, pomelo, mango, and dragon fruit) that may affect drug metabolism,from 48 hours before administration until the end of the study; 16. Participants who cannot tolerate blood collection with intravenous indwelling needles or blood fainting; 17. Participants with difficulty in swallowing capsules; 18. Participants whose female partners plan to conceive within 3 months; 19. The investigator believes that there are other unsuitable factors to participate this trial.
Where it's running
-
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China Recruiting
Study contacts
- Principal investigator: Huan Zhou — The First Affiliated Hospital of Anhui Medical University
- Study coordinator: Huaqing Duan
- Email: huaqing.duan@vigonvita.cn
- Phone: 18061926005
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.