NCT04616079

Ascending Dose Study of the Safety and Tolerability of REGN6490 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of REGN6490 in Healthy Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (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 ascending intravenous (IV) and subcutaneous (SC) doses of REGN6490 in healthy adult participants The secondary objectives of the study are to: * Characterize the pharmacokinetic (PK) profile of single IV and SC doses of REGN6490 in healthy adult participants * Assess immunogenicity of REGN6490 in healthy adult participants dosed with a single IV or SC dose of REGN6490

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	REGN6490	Single dose of REGN6490
DRUG	Placebo	Placebo matching single dose of REGN6490

Timeline

• Start date: 2020-11-19
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-11-04
• Last updated: 2021-11-11

Locations

1 site across 1 country: Belgium