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Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01893528
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : November 10, 2014
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: REGN2009 Other: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: REGN2009 dose level 1
Cohort A - REGN2009 or placebo; Cohort B - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
Drug: REGN2009
Other: placebo
Experimental: REGN2009 dose level 2
Cohort C - REGN2009 or placebo; Cohort D - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
Drug: REGN2009
Other: placebo
Experimental: REGN2009 dose level 3
Cohort E - REGN2009 or placebo; Cohort F - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
Drug: REGN2009
Other: placebo



Primary Outcome Measures :
  1. Number of TEAEs [ Time Frame: day 1 to day 106/ visit 15 ]
    The primary endpoint in this study is the incidence and severity of Treatment Emergent Adverse Events (TEAEs) in healthy volunteers treated with REGN2009 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 15.



Information from the National Library of Medicine

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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:

  1. Healthy men and women ages 18 to 65 years inclusive
  2. Body mass index between 18.0 kg/m^2 and 30.0 kg/m^2, inclusive

Exclusion Criteria:

  1. Pregnant or breast-feeding women
  2. Any clinically significant abnormalities observed during screening (day -21 to day -2)
  3. 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
  4. History of drug or alcohol abuse within a year prior to the screening visit (day -21 to day -2)
  5. Hospitalization for any reason within 60 days of the screening visit (day -21 to day -2)
  6. Participation in any clinical research study within 30 days of the screening visit (day -21 to day -2) or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
  7. History of a hypersensitivity reaction to doxycycline or similar compound
  8. Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
  9. Previous adverse experience to any biological investigational or therapeutic agent
  10. Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.


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): NCT01893528


Locations
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United States, Maryland
Baltimore, Maryland, United States
United States, Ohio
Cincinnati, Ohio, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01893528     History of Changes
Other Study ID Numbers: R2009-HV-1304
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014