Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN9933, a Monoclonal Antibody Against Factor XI, in Healthy Adult Subjects
The primary objective of the study is to evaluate the safety and tolerability of single doses of REGN9933 in healthy participants The secondary objectives of the study are to: - Evaluate the effects of single doses of REGN9933 on intrinsic/common pathway coagulation - Evaluate the effects of single doses of REGN9933 on extrinsic/common pathway coagulation - Characterize the drug concentration profiles and pharmacokinetic (PK) following single escalating doses of REGN9933 - Characterize the concentration profiles of total FXI following single escalating doses of REGN9933 - Assess the immunogenicity of single doses of REGN9933
n/a
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