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

This study has been completed.

Sponsor:

Collaborator:

Sanofi

Information provided by:

Regeneron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01074372

First received: February 22, 2010

Last updated: May 4, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 22, 2010

Last Updated Date

May 4, 2011

Start Date ^ICMJE

March 2010

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: 106 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01074372 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

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 REGN727 (SAR236553) in Healthy Volunteers

Official Title ^ICMJE

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

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 an injection under the skin 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy Volunteers

Intervention ^ICMJE

Biological: REGN727
4 cohorts (dose 1, 2, 3, 4)
Biological: Placebo
4 cohorts (dose 1, 2, 3, 4)

Study Arm (s)

Experimental: Cohort 1
Dose 1 versus placebo
Interventions:
- Biological: REGN727
- Biological: Placebo
Experimental: Cohort 2
Dose 2 versus placebo
Interventions:
- Biological: REGN727
- Biological: Placebo
Experimental: Cohort 3
Dose 3 versus placebo
Interventions:
- Biological: REGN727
- Biological: Placebo
Experimental: Cohort 4
Dose 4 versus placebo
Interventions:
- Biological: REGN727
- Biological: Placebo

Publications *

Stein EA, Mellis S, Yancopoulos GD, Stahl N, Logan D, Smith WB, Lisbon E, Gutierrez M, Webb C, Wu R, Du Y, Kranz T, Gasparino E, Swergold GD. Effect of a monoclonal antibody to PCSK9 on LDL cholesterol. N Engl J Med. 2012 Mar 22;366(12):1108-18.

* 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

November 2010

Primary Completion Date

November 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 <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 females.
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.

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

NCT01074372

Other Study ID Numbers ^ICMJE

R727-CL-0904

Has Data Monitoring Committee

Responsible Party

Gary Swergold, MD,PhD, Regeneron Pharmaceuticals

Study Sponsor ^ICMJE

Regeneron Pharmaceuticals

Collaborators ^ICMJE

Sanofi

Investigators ^ICMJE

Study Director:

Gary Swergold, MD, PhD

Regeneron Pharmaceuticals

Information Provided By

Regeneron Pharmaceuticals

Verification Date

May 2011

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

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