Ascending Dose Study of the Safety and Tolerability of REGN668(SAR231893) in Normal Healthy Volunteers

• Sponsor: Regeneron Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01015027
• Collaborator: Sanofi (Industry)
• Enrollment: 48
• Location: 1
• Arms: 4
• Duration (Months): 9
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

This study will test the safety and tolerability (how the body reacts to the drug) of REGN668 and placebo (an inactive substance that contains no medicine) in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: REGN668	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study of the Safety and Tolerability of Intravenously Administered REGN668 in Healthy Volunteers
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose 1 (3:1, active:placebo)	Biological: REGN668; 4 IV Cohorts (Dose 1, 2, 3, & 4)
Experimental: Dose 2 (3:1, active:placebo)	Biological: REGN668; 4 IV Cohorts (Dose 1, 2, 3, & 4)
Experimental: Dose 3 (3:1, active:placebo)	Biological: REGN668; 4 IV Cohorts (Dose 1, 2, 3, & 4)
Experimental: Dose 4 (3:1, active:placebo)	Biological: REGN668; 4 IV Cohorts (Dose 1, 2, 3, & 4)

Outcome Measures

Primary Outcome Measures

1. The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN668 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 85/visit 11. [85 days]

Secondary Outcome Measures

1. Pharmacokinetics: Serum concentrations of REGN668 over time. [85 days]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Male or female 18 to 65 years of age.

2. Weight > 50 kg and < 120 kg.

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

4. Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.

5. 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.

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

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

Exclusion Criteria:

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

2. Pregnant or breast-feeding women.

3. 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.

4. Hospitalization for any reason within 60 days of screening (visit 1).

5. Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C, and/or positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C antibody (HCV).

6. Previous exposure to any therapeutic or investigational biological agent. results.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Baltimore	Maryland	United States

Sponsors and Collaborators

• Regeneron Pharmaceuticals
• Sanofi

Investigators

• Study Director: Allen Radin, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01015027
• Other Study ID Numbers: R668-AS-0907
• First Posted: Nov 17, 2009
• Last Update Posted: Jun 17, 2013
• Last Verified: Jun 1, 2013

Study Results

No Results Posted as of Jun 17, 2013