NCT06665828

Phase 1 Safety and Tolerability Study of REGN9533 in Healthy Adults

A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN9533, a Monoclonal Antibody Against Factor XII, in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of this clinical trial is to see how safe and tolerable the clinical trial drug (REGN9533) is in healthy participants. This is the first time that REGN9533 will be given to humans. After the clinical trial drug has been tested in healthy participants, future studies with REGN9533 will focus on participants with thromboembolic (blocking of blood vessels) diseases which include blood clots. REGN9533 is a drug that is only used in clinical studies. The clinical trial is looking at: * The side effects REGN9533 might cause * How much REGN9533 is in the blood at different times * How the body reacts to REGN9533 * If the body makes antibodies to REGN9533 (unwanted immune response, which may cause REGN9533 to not work as well) * What is the best dose of REGN9533

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	REGN9533	Administered per the protocol
DRUG	Matching Placebo	Administered per the protocol.

Timeline

• Start date: 2025-03-04
• Primary completion: 2026-01-29
• Completion: 2026-01-29
• First posted: 2024-10-30
• Last updated: 2026-02-06

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study