NCT04616105

Study of the Safety, Tolerability, and Pharmacokinetics of REGN6490 in Healthy Japanese Adult Volunteers

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the safety and tolerability of 3 single ascending subcutaneous (SC) doses and 1 single intravenous (IV) dose of REGN6490 in healthy first-generation Japanese adult participants The secondary objectives of the study are: * To characterize the pharmacokinetic (PK) profile of single SC and IV doses of REGN6490 in healthy first-generation Japanese adult participants * Assess immunogenicity of REGN6490 in healthy first-generation Japanese 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: 2020-11-18
• Primary completion: 2021-05-28
• Completion: 2021-05-28
• First posted: 2020-11-04
• Last updated: 2021-11-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study