NCT05603195

A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7508, a Monoclonal Antibody Against Factor XI, in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is researching an experimental drug called REGN7508 (called "study drug"). The aim of this study is to see how safe and tolerable the study drug is in healthy participants. This study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	REGN7508 (IV)	Administered sequential, ascending single intravenous (IV) dose
DRUG	REGN7508 (SC)	Administered sequential, ascending single subcutaneous (SC) dose
DRUG	Matching Placebo (IV)	Administered sequential, ascending single intravenous (IV) dose
DRUG	Matching Placebo (SC)	Administered sequential, ascending single subcutaneous (SC) dose

Timeline

• Start date: 2023-01-12
• Primary completion: 2024-09-17
• Completion: 2024-09-17
• First posted: 2022-11-02
• Last updated: 2024-10-01

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study