At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating REGN9933 and Placebo for Healthy Volunteers. Completed, enrolled 56 participants across 1 site.
Detailed Summary
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
Study Details
Timeline
Interventions
Administered intravenously (IV) or subcutaneous (SC) per the protocol
Placebo to match REGN9933 in same form; placebo administered IV or SC per the protocol