NCT06766929

A Phase I Clinical Study of VSA012 in Healthy Volunteers

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VSA012 After Single Ascending Doses in Healthy Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Visirna Therapeutics HK Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The complement system is an important component of the innate immune system. Abnormal activation, inadequate regulation and control of the complement system, as well as impaired and dysfunctional effector functions, underlie complement mediated diseases. VSA012 targeting complement system has the potential to treat a variety of diseases associated with abnormal activation of the complement system (e.g. PNH) .The purpose of VSA012-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VSA012 Injection in adult healthy volunteers (HVs). HVs will receive a single dose of VSA012 or placebo.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	VSA012	subcutaneous injection
DRUG	Placebo	subcutaneous injection

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2025-01-09
• Last updated: 2025-01-09