NCT03645746

Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN5069 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (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 doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in healthy male and female participants. The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity of REGN5069 in healthy participants administered single IV or SC doses of REGN5069

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	REGN5069	REGN5069 will be administered by IV infusion or SC injection
DRUG	Placebo	Placebo-matching REGN5069

Timeline

• Start date: 2018-08-23
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2018-08-24
• Last updated: 2019-11-26

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study