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
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Biological: REGN727
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind,Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of Subcutaneously Administered REGN727 in Healthy Volunteers

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Dose 1 versus placebo
Biological: REGN727
4 cohorts (dose 1, 2, 3, 4)
Biological: Placebo
4 cohorts (dose 1, 2, 3, 4)
Experimental: Cohort 2
Dose 2 versus placebo
Biological: REGN727
4 cohorts (dose 1, 2, 3, 4)
Biological: Placebo
4 cohorts (dose 1, 2, 3, 4)
Experimental: Cohort 3
Dose 3 versus placebo
Biological: REGN727
4 cohorts (dose 1, 2, 3, 4)
Biological: Placebo
4 cohorts (dose 1, 2, 3, 4)
Experimental: Cohort 4
Dose 4 versus placebo
Biological: REGN727
4 cohorts (dose 1, 2, 3, 4)
Biological: Placebo
4 cohorts (dose 1, 2, 3, 4)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074372

Locations
United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Gary Swergold, MD, PhD Regeneron Pharmaceuticals
  More Information

No publications provided by Regeneron Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gary Swergold, MD,PhD, Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01074372     History of Changes
Other Study ID Numbers: R727-CL-0904
Study First Received: February 22, 2010
Last Updated: May 4, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 26, 2014