A Phase I Clinical Study of VSA012 in Healthy Volunteers

Phase 1

Not yet recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: VSA012; Drug: Placebo

• Registration Number: NCT06766929
• Lead Sponsor: Visirna Therapeutics HK Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-29
• Status Verified: 2025-01
• Study Start: 2025-01
• Study First Submitted QC: 2025-01-04
• Last Update Submitted: 2025-01-04
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Willing to provide written informed consent and to comply with study requirements
• Participants must be non-pregnant/non-lactating
• Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine.
• Body Mass Index (BMI) between 18.0 and 30.0 kg/m2
• No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the Investigator, could adversely impact participant safety or adversely impact study results.

Exclusion Criteria

• History of recurrent or chronic infections including infections caused by encapsulated bacterial organisms or viruses
• History of active bacterial, viral, or fungal infection within 14 days prior to treatment administrations
• Seropositive for Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
• History of meningococcal infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VSA012	VSA012	Single ascending doses of VSA012
Placebo	Placebo	Single ascending doses of placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)	up to Day 180

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of VSA012: Maximum Observed Plasma Concentration (Cmax)	Up to 48 hours post-dose
PK of VSA012: Time to Maximum Observed Plasma Concentration (Tmax)	Up to 48 hours post-dose
PK of VSA012: Area Under the Plasma Concentration Versus Time Curve	Up to 48 hours post-dose
Change from Baseline in Serum Complement Factor B (CFB)	Up to Day 180
Change from Baseline in Serum Complement Alternative Pathway (CAP)	up to Day 180
The incidence of ADA	up to Day 180