Overview

A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease

Status:
Active, not recruiting
Trial end date:
2022-01-05
Target enrollment:
Participant gender:
Summary
Primary Objective: To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020 Secondary Objectives: To assess, in participants with cold agglutinin disease, after a single dose of intravenous (IV) BIVV020: - The effect of BIVV020 on complement mediated hemolysis - The pharmacodynamics (PD) of BIVV020 relating to complement inhibition - The pharmacokinetics (PK) of BIVV020 - The immunogenicity of BIVV020
Phase:
Phase 1
Details
Lead Sponsor:
Bioverativ, a Sanofi company
Sanofi
Treatments:
Agglutinins
Cold agglutinins