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

• Sponsor: Regeneron Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01026597
• Collaborator: Sanofi (Industry)
• Enrollment: 40
• Location: 1
• Arms: 5
• Duration (Months): 11
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: REGN727; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized,Double-Blind,Placebo-Controlled,Ascending,Single-Dose Study of the Safety,Tolerability and Bioeffect of Intravenously Administered REGN727 in Healthy Volunteers
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Dose 1 versus placebo	Drug: REGN727; 5 IV cohorts (dose 1, 2, 3, 4, and 5); Drug: Placebo; 5 IV cohorts (dose 1, 2, 3, 4, and 5)
Experimental: Cohort 2 Dose 2 versus placebo	Drug: REGN727; 5 IV cohorts (dose 1, 2, 3, 4, and 5); Drug: Placebo; 5 IV cohorts (dose 1, 2, 3, 4, and 5)
Experimental: cohort 3 Dose 3 versus placebo	Drug: REGN727; 5 IV cohorts (dose 1, 2, 3, 4, and 5); Drug: Placebo; 5 IV cohorts (dose 1, 2, 3, 4, and 5)
Experimental: cohort 4 Dose 4 versus placebo	Drug: REGN727; 5 IV cohorts (dose 1, 2, 3, 4, and 5); Drug: Placebo; 5 IV cohorts (dose 1, 2, 3, 4, and 5)
Experimental: cohort 5 Dose 5 versus placebo	Drug: REGN727; 5 IV cohorts (dose 1, 2, 3, 4, and 5); Drug: Placebo; 5 IV cohorts (dose 1, 2, 3, 4, and 5)

Outcome Measures

Primary Outcome Measures

1. The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106. [106 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female 18 to 65 years of age.

• Weight> 50 kg and <95 kg inclusive

• For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day 1.

• For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant during the full duration of the study.

• Willing, committed, and able to return for all clinic visits and complete all study-related procedures.

• Able to read, understand and willing to sign the informed consent form.

Exclusion Criteria:

• Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.

• Pregnant or breast-feeding women.

• Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.

• Hospitalization for any reason within 60 days of screening.

• Known history of Human Immunodeficiency Virus (HIV) antibody; and/or positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit.

• Previous exposure to any therapeutic or investigational biological agent.

• History of alcohol or substance abuse within previous 5 years.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Overland Park	Kansas	United States

Sponsors and Collaborators

• Regeneron Pharmaceuticals
• Sanofi

Investigators

• Study Director: Gary Swergold, MD, PhD, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01026597
• Other Study ID Numbers: R727-CL-0902
• First Posted: Dec 4, 2009
• Last Update Posted: Jan 27, 2015
• Last Verified: Dec 1, 2011

Study Results

No Results Posted as of Jan 27, 2015