CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
VSA001 injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05757596
NCT05757596Phase 1Completed
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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

Visirna Therapeutics HK Limited·interventional·Posted Mar 7, 2023·Updated Mar 20, 2025

In Brief

A Phase 1 clinical trial evaluating VSA001 injection and Placebo for Healthy Adult Volunteers. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adult Volunteers
CountriesChina
CollaboratorsArrowhead Pharmaceuticals

Timeline

Phase 1CompletedFinished
202420252026
First PostedMar 7, 2023
Enrollment StartMay 17, 2023
Primary CompletionSep 25, 2023
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.3 years ago

Interventions

VSA001 injectiondrug

The active drug is VSA001 injection. The active pharmaceutical ingredient (API) contained in VSA001 is a synthetic, double-stranded, hepatocyte targeted NAG-conjugated RNAi.

Placebodrug

0.9% Saline, volume matched