NCT05757596

Study of VSA001 Injection in Chinese Healthy Adult Volunteers

A Phase 1 Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Effects of a Single Dose of VSA001 Injection in Chinese Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Visirna Therapeutics HK Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of VSA001 injection in Chinese healthy adult volunteers. Eligible enrolled participants will initially receive VSA001 injection at the assigned dose level.

Conditions

• Healthy Adult Volunteers

Interventions

Type	Name	Description
DRUG	VSA001 injection	The active drug is VSA001 injection. The active pharmaceutical ingredient (API) contained in VSA001 is a synthetic, double-stranded, hepatocyte targeted NAG-conjugated RNAi.
DRUG	Placebo	0.9% Saline, volume matched

Timeline

• Start date: 2023-05-17
• Primary completion: 2023-09-25
• Completion: 2023-12-31
• First posted: 2023-03-07
• Last updated: 2025-03-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study