NCT07302269

Study of the Safety, Tolerability, Pharmacokinetics of VV261 Tablets in Chinese Healthy Volunteers

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of a Single Oral Dose of VV261 Tablets in Chinese Healthy Volunteers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: All
• 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 VV261 tablets in healthy adults.

Detailed description

The study is designed to enroll 58 volunteers. The pilot study is an open-labelled study where both volunteers receive 5 mg VV261 tablets. The formal study, conducted as a double-blind study, comprise 7dose groups with 8 volunteers (both sexes) each. Volunteers will be randomly assigned to receive either the VV261 tablets or placebo in a ratio of 6:2. The formal study's dose groups are designed as 20 mg, 50 mg, 150 mg, 300 mg, 500 mg, 750 mg, and 1000 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	VV261 5mg group	2 subjects will receive VV261 5mg, orally
DRUG	VV261 20mg Group	6 subjects receive VV261 20mg,orally; 2 subjects will receive placebo,orally.
DRUG	VV261 50mg group	6 subjects receive VV261 50mg,orally; 2 subjects will receive placebo,orally.
DRUG	VV261 100mg group	6 subjects receive VV261 100mg,orally; 2 subjects will receive placebo,orally.
DRUG	VV261 150mg group	6 subjects receive VV261 150mg,orally; 2 subjects will receive placebo,orally.
DRUG	VV261 300mg group	6 subjects receive VV261 300mg,orally; 2 subjects will receive placebo,orally.
DRUG	VV261 500mg group	6 subjects receive VV261 500mg,orally; 2 subjects will receive placebo,orally.
DRUG	VV261 750mg group	6 subjects receive VV261 750mg,orally; 2 subjects will receive placebo,orally.
DRUG	VV261 1000mg group	6 subjects receive VV261 1000mg,orally; 2 subjects will receive placebo,orally.

Timeline

• Start date: 2026-01-04
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2025-12-24
• Last updated: 2026-03-03

Locations

1 site across 1 country: China