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

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

Timeline

Start

2021-10-27

Primary completion

2023-04-04

Completion

2023-04-04

Publications

• Chalothorn D, Kithcart AP, Marin E, Somersan-Karakaya S, Lai K, Cauwberghs F, Ackroyd JPR, Mohammadi K, Shrestha A, Ehrlich GK, Rafique A, Chatterjee I, Saotome K, Franklin MC, Murphy AJ, Olson WC, Olenchock BA, Herman GA, Gutstein DE, Sirulnik A, Yancopoulos GD, Morton LG. Anticoagulation with mechanistically distinct FXI/FXIa antibodies amrecibart (REGN9933A2) and cenvacibart (REGN7508Cat). Blood. 2026 Jun 11:blood.2025032276. doi: 10.1182/blood.2025032276. Online ahead of print.

Drugs

Indications

No indication recorded.