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

February 22, 2010
May 4, 2011
March 2010
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01074372 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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 Subcutaneously Administered REGN727 in Healthy Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Volunteers
  • Biological: REGN727
    4 cohorts (dose 1, 2, 3, 4)
  • Biological: Placebo
    4 cohorts (dose 1, 2, 3, 4)
  • 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
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. doi: 10.1056/NEJMoa1105803.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01074372
R727-CL-0904
No
Gary Swergold, MD,PhD, Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Gary Swergold, MD, PhD Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
May 2011

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