Safety, tolerability, and dosing of VV913 capsules in healthy Chinese men
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of a Single Oral Dose of VV913 Capsules in Chinese Healthy Participants
Run by Vigonvita Life Sciences · NCT07372703 · Data updated 2026-11-12
This test gives single, increasing doses of VV913 or placebo to healthy Chinese men aged 18–45 to see if the drug is safe and how the body processes it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | Men only |
| Enrollment | 56 (estimated) |
| Sponsor | Vigonvita Life Sciences Industry-sponsored |
| Locations | 1 site (Hefei, Anhui) |
| Status | Recruiting |
| Started | January 29, 2026 |
| Main results expected | September 2026 |
| Study ends | October 2026 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT07372703 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy Chinese men aged 18–45 years who weigh at least 50 kg, have a BMI of 19–26 kg/m2, meet screening exam criteria, agree to contraception, and can follow the protocol are eligible.
✕Probably not a fit
People with allergy histories, relevant central nervous system or cardiovascular conditions, women, or anyone who does not meet the strict health and age criteria are unlikely to gain benefit from participation.
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 randomized, double-blind, placebo-controlled, single ascending-dose Phase 1 design enrolling 56 healthy male participants split into seven dose cohorts. Each cohort (8 participants) is randomized 6:2 to receive VV913 or placebo with planned doses from 1 mg up to 40 mg. The study will collect safety, tolerability, and pharmacokinetic data after a single administration, with the option to adjust dosing based on observed safety or PK results. All participants undergo screening labs, ECG, chest CT, and follow-up visits to monitor for adverse events and drug levels.
Why it matters
Potential benefit: If VV913 is safe and has favorable pharmacokinetics, it could progress to patient studies and potentially become a future treatment option.
How similar studies have gone: Single-ascending-dose, randomized, double-blind, placebo-controlled Phase 1 designs are standard and have successfully defined safety and PK for many investigational drugs, but VV913 itself appears novel with no public efficacy data yet.
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 ,electrocardiogram examination chest CT 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.