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

This study has been completed.

Sponsor:

Collaborator:

Sanofi

Information provided by:

Regeneron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01015027

First received: November 10, 2009

Last updated: July 5, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 10, 2009

Last Updated Date

July 5, 2011

Start Date ^ICMJE

October 2009

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: 85 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01015027 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics: Serum concentrations of REGN668 over time. [ Time Frame: 85 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study of the Safety and Tolerability of Intravenously Administered REGN668 in Healthy Volunteers

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Biological: REGN668

4 IV Cohorts (Dose 1, 2, 3, & 4)

Study Arm (s)

Experimental: Dose 1
(3:1, active:placebo)

Intervention: Biological: REGN668
Experimental: Dose 2
(3:1, active:placebo)

Intervention: Biological: REGN668
Experimental: Dose 3
(3:1, active:placebo)

Intervention: Biological: REGN668
Experimental: Dose 4
(3:1, active:placebo)

Intervention: Biological: REGN668

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female 18 to 65 years of age.
Weight > 50 kg and < 120 kg.
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.
Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.
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:

Onset 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 (visit 1).
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).
Previous exposure to any therapeutic or investigational biological agent. results.
History of alcohol or substance abuse within previous 5 years.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01015027

Other Study ID Numbers ^ICMJE

R668-AS-0907

Has Data Monitoring Committee

Responsible Party

Allen Radin, Regeneron Pharmaceuticals

Study Sponsor ^ICMJE

Regeneron Pharmaceuticals

Collaborators ^ICMJE

Sanofi

Investigators ^ICMJE

Study Director:

Allen Radin

Regeneron Pharmaceuticals

Information Provided By

Regeneron Pharmaceuticals

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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