A Phase I Clinical Study of VSA012 in Healthy Volunteers

NCT06766929 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: VSA012-1001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)

  up to Day 180

Secondary Outcomes (6)

• 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

Study Arms (5)

Cohort1

EXPERIMENTAL

Drug: VSA012; Drug: Placebo

Cohort2

EXPERIMENTAL

Drug: VSA012; Drug: Placebo

cohort3

EXPERIMENTAL

Drug: VSA012; Drug: Placebo

Cohort4

EXPERIMENTAL

Drug: VSA012; Drug: Placebo

cohort5

EXPERIMENTAL

Drug: VSA012; Drug: Placebo

Interventions

VSA012 DRUG

VSA012 injection

Cohort1; Cohort2; Cohort4; cohort3; cohort5

Placebo DRUG

Placebo

Cohort1; Cohort2; Cohort4; cohort3; cohort5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bisirna Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 9, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)