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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01074372
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : January 27, 2015
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: REGN727 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Dose 1 versus placebo
 Drug: REGN727
4 cohorts (dose 1, 2, 3, 4)

Drug: Placebo
4 cohorts (dose 1, 2, 3, 4)
Experimental: Cohort 2
Dose 2 versus placebo
 Drug: REGN727
4 cohorts (dose 1, 2, 3, 4)

Drug: Placebo
4 cohorts (dose 1, 2, 3, 4)
Experimental: Cohort 3
Dose 3 versus placebo
 Drug: REGN727
4 cohorts (dose 1, 2, 3, 4)

Drug: Placebo
4 cohorts (dose 1, 2, 3, 4)
Experimental: Cohort 4
Dose 4 versus placebo
 Drug: REGN727
4 cohorts (dose 1, 2, 3, 4)

Drug: Placebo
4 cohorts (dose 1, 2, 3, 4)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074372


Locations
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United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Gary Swergold, MD, PhD Regeneron Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01074372    
Other Study ID Numbers: R727-CL-0904
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: May 2011