NCT07372703

Study of the Safety, Tolerability, Pharmacokinetics of VV913 Capsules in Chinese Healthy Participants

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of a Single Oral Dose of VV913 Capsules in Chinese Healthy Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, single ascending-dose study to evaluate the safety, tolerability and pharmacokinetics characteristics of VV913 Capsules in healthy adults.

Detailed description

The study is designed to enroll 56 participants. The study , conducted as a double-blind study, comprise 7 dose groups with 8 participants each. Participants will be randomly assigned to receive either the VV913 Capsules or placebo in a ratio of 6:2. Dose groups are designed as 1 mg, 2 mg, 4 mg, 8 mg, 15 mg, 25 mg, and 40 mg. Based on observed tolerability and safety data or obtained pharmacokinetic data, adjustments are allowed at all dose levels in the clinical trial.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	VV913 1mg group	6 participants will receive VV913 1mg orally; 2 participants will receive placebo orally.
DRUG	VV913 2mg group	6 participants will receive VV913 2mg orally; 2 participants will receive placebo orally.
DRUG	VV913 4mg group	6 participants will receive VV913 4mg orally; 2 participants will receive placebo orally.
DRUG	VV913 8mg group	6 participants will receive VV913 8mg orally; 2 participants will receive placebo orally.
DRUG	VV913 15mg group	6 participants will receive VV913 15mg orally; 2 participants will receive placebo orally.
DRUG	VV913 25mg group	6 participants will receive VV913 25mg orally; 2 participants will receive placebo orally.
DRUG	VV913 40mg group	6 participants will receive VV913 40mg orally; 2 participants will receive placebo orally.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2026-01-28
• Last updated: 2026-01-28