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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 (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01015027
First received: November 10, 2009
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: REGN668
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study of the Safety and Tolerability of Intravenously Administered REGN668 in Healthy Volunteers

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 48
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1
(3:1, active:placebo)
Biological: REGN668
4 IV Cohorts (Dose 1, 2, 3, & 4)
Experimental: Dose 2
(3:1, active:placebo)
Biological: REGN668
4 IV Cohorts (Dose 1, 2, 3, & 4)
Experimental: Dose 3
(3:1, active:placebo)
Biological: REGN668
4 IV Cohorts (Dose 1, 2, 3, & 4)
Experimental: Dose 4
(3:1, active:placebo)
Biological: REGN668
4 IV 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:

  1. Male or female 18 to 65 years of age.
  2. Weight > 50 kg and < 120 kg.
  3. 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.
  4. Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.
  5. 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.
  6. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
  7. Able to read, understand and willing to sign the informed consent form.

Exclusion Criteria:

  1. Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
  2. Pregnant or breast-feeding women.
  3. 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.
  4. Hospitalization for any reason within 60 days of screening (visit 1).
  5. 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).
  6. Previous exposure to any therapeutic or investigational biological agent. results.
  7. 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: NCT01015027

Locations
United States, Maryland
Baltimore, Maryland, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Allen Radin Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01015027     History of Changes
Other Study ID Numbers: R668-AS-0907
Study First Received: November 10, 2009
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 24, 2014