NCT05102136

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 in Adult Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	REGN9933	Administered intravenously (IV) or subcutaneous (SC) per the protocol
DRUG	Placebo	Placebo to match REGN9933 in same form; placebo administered IV or SC per the protocol

Timeline

• Start date: 2021-10-27
• Primary completion: 2023-04-04
• Completion: 2023-04-04
• First posted: 2021-11-01
• Last updated: 2023-05-03

Locations

1 site across 1 country: Belgium