Not Yet RecruitingEarly Phase 1

Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV913 Capsules

24 participantsStarted 2026-04-01

Plain-language summary

This study is a single-center, randomized, double-blind, placebo-controlled, dose-escalation trial to assess the safety, tolerability, pharmacokinetics （PK） of multiple doses of VV913 in Chinese healthy adult participants.

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged 18 to 45 years old, males ;
✓. Males weight no less than 50 kg, with body mass index of 19 to 26 kg/m\^2;
✓. Vital signs examination, physical examination, laboratory examination ,Chest X-ray are normal or considered abnormal without clinical significance by the investigator;
✓. Participants who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;
✓. 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

✕. Participants with hypersensitivity to preparation or any of the excipients;
✕. Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
✕. 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 a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial;
✕. 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;
✕. Participating in any clinical trial and taking clinical trial drugs within 90 days before screening;
✕. Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before screening;
✕. 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;

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: Baseline to 6 days after the last administration

Cmax

Timeframe: Baseline to 72 hours after the last administration

AUC0-∞

Timeframe: Baseline to 72 hours after the last administration

Tmax

Timeframe: Baseline to 72 hours after the last administration

t1/2

Timeframe: Baseline to 72 hours after the last administration

Apparent Clearance Rate（CL/F）

Timeframe: Baseline to 72 hours after the last administration

Vd/F

Timeframe: Baseline to 72 hours after the last administration

λz

Timeframe: Baseline to 72 hours after the last administration

Trial details

NCT IDNCT07507838

SponsorVigonvita Life Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Huaqing Duan

18061926005 huaqing.duan@vigonvita.cn

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged 18 to 45 years old, males ;
✓. Males weight no less than 50 kg, with body mass index of 19 to 26 kg/m\^2;
✓. Vital signs examination, physical examination, laboratory examination ,Chest X-ray are normal or considered abnormal without clinical significance by the investigator;
✓. Participants who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;
✓. 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

✕. Participants with hypersensitivity to preparation or any of the excipients;
✕. Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
✕. 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 a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial;
✕. 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;
✕. Participating in any clinical trial and taking clinical trial drugs within 90 days before screening;
✕. Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before screening;
✕. 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;

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: Baseline to 6 days after the last administration

Cmax

Timeframe: Baseline to 72 hours after the last administration

AUC0-∞

Timeframe: Baseline to 72 hours after the last administration

Tmax

Timeframe: Baseline to 72 hours after the last administration

t1/2

Timeframe: Baseline to 72 hours after the last administration

Apparent Clearance Rate（CL/F）

Timeframe: Baseline to 72 hours after the last administration

Vd/F

Timeframe: Baseline to 72 hours after the last administration

λz

Timeframe: Baseline to 72 hours after the last administration