NCT01026597

Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy Volunteers

A Randomized,Double-Blind,Placebo-Controlled,Ascending,Single-Dose Study of the Safety,Tolerability and Bioeffect of Intravenously Administered REGN727 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	REGN727	5 IV cohorts (dose 1, 2, 3, 4, and 5)
DRUG	Placebo	5 IV cohorts (dose 1, 2, 3, 4, and 5)

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-12-04
• Last updated: 2015-01-27

Locations

1 site across 1 country: United States