NCT03115996

Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN3918 in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously and Subcutaneously Administered Human Monoclonal Antibody REGN3918 in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses and a multiple dose regimen.

Detailed description

Participants will be randomized to single IV or SC or multiple dose treatment with REGN3918 or matched placebo.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	REGN3918	Intravenous (IV) or Subcutaneous (SC)
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2017-05-10
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2017-04-14
• Last updated: 2018-09-26

Locations

1 site across 1 country: United Kingdom