NCT06105151

Study of the Safety, Tolerability, Pharmacokinetics and Food Effects of VV119 Capsules in Chinese Healthy Volunteers

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Food Effects of a Single Oral VV119 Capsule in Healthy Chinese Volunteers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study will consist of 2 parts: Part Ⅰ - Single Ascending Dose (SAD) study, Part Ⅱ - Food Effect (FE) study

Detailed description

Part Ⅰ were designed as single-center, randomized, double-blind, placebo-controlled, dose-escalation trials to assess the safety, tolerability, pharmacokinetic (PK) of single oral doses of VV119 in healthy adult subjects. Part Ⅱ is a single-center, randomized, open label, 2×2 crossover design to assess the high-fat meal effects on PK of a single oral dose of VV119 in healthy adult subjects.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	VV119(SAD)	VV119 0.2 mg Group: 2 subjects will receive VV119 0.2 mg, orally; VV119 0.5 mg Group: 6 subjects will receive VV119 0.5 mg, orally; VV119 1 mg Group: 6 subjects will receive VV119 1 mg, orally; VV119 2 mg Group: 6 subjects will receive VV119 2 mg, orally; VV119 3 mg Group:6 subjects will receive VV119 3 mg, orally; VV119 4.5 mg Group:6 subjects will receive VV119 4.5 mg, orally; VV119 6 mg Group:6 subjects will receive VV119 6 mg, orally; VV119 8 mg Group:6 subjects will receive VV119 8 mg, orally; VV119 10 mg Group:6 subjects will receive VV119 10 mg, orally;
DRUG	VV119 Placebo(SAD)	VV119 0.5 mg Group: 2 subjects will receive VV119 Placebo 0.5 mg, orally; VV119 1 mg Group: 2 subjects will receive VV119 Placebo 1 mg, orally; VV119 2 mg Group: 2 subjects will receive VV119 Placebo 2 mg, orally; VV119 3 mg Group:2 subjects will receive VV119 Placebo 3 mg, orally; VV119 4.5 mg Group:2 subjects will receive VV119 Placebo 4.5 mg, orally; VV119 6 mg Group:2 subjects will receive VV119 Placebo 6 mg, orally; VV119 8 mg Group:2 subjects will receive VV119 Placebo 8 mg, orally; VV119 10 mg Group:2 subjects will receive VV119 Placebo 10 mg, orally;
DRUG	VV119(FE)	A：2 mg VV119, following an overnight fast of at least 10 hours for Period 1; 2mg VV119, administered 30 minutes after the start of a high-fat meal for Period 2; B: 2mg VV119, administered 30 minutes after the start of a high-fat meal for Period 1;2mg VV119, following an overnight fast of at least 10 hours for Period 2；

Timeline

• Start date: 2023-10-27
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-10-27
• Last updated: 2025-06-11

Locations

1 site across 1 country: China