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A Phase I Clinical Study of VSA012 in Healthy Volunteers
Sponsor: Bisirna Therapeutics (Suzhou) Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-01-20
Completion Date
2027-06
Last Updated
2026-05-04
Healthy Volunteers
Yes
Conditions
Interventions
VSA012
VSA012 injection
Placebo
Placebo
Locations (1)
Peking University Third Hospital
Beijing, Beijing Municipality, China