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Intravenous/Subcutaneous FIH Study of REGN1154 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01540539
First received: February 23, 2012
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to study the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of REGN1154 in normal healthy subjects.


Condition Intervention Phase
Healthy Volunteers
 Drug: REGN1154 or placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Total number and severity of TEAEs [ Time Frame: Day 1 through Day 113 ] [ Designated as safety issue: Yes ]
    TEAEs (Treatment-emergent adverse events)


Secondary Outcome Measures:
  • Serum concentration [ Time Frame: Day 1 through Day 113 ] [ Designated as safety issue: No ]
    Serum concentrations of REGN1154 over time

  • Presence or absence of antibodies [ Time Frame: Day 1 through Day 113 ] [ Designated as safety issue: No ]
    Presence or absence of antibodies against REGN1154 over time.


Enrollment: 44
Study Start Date: March 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosing cohort 1 Drug: REGN1154 or placebo
Participants will receive active drug or placebo
Experimental: Dosing cohort 2 Drug: REGN1154 or placebo
Participants will receive active drug or placebo
Experimental: Dosing cohort 3 Drug: REGN1154 or placebo
Participants will receive active drug or placebo
Experimental: Dosing cohort 4 Drug: REGN1154 or placebo
Participants will receive active drug or placebo
Experimental: Dosing cohort 5 Drug: REGN1154 or placebo
Participants will receive active drug or placebo
Experimental: Dosing cohort 6 Drug: REGN1154 or placebo
Participants will receive active drug or placebo
Experimental: Dosing cohort 7 Drug: REGN1154 or placebo
Participants will receive active drug or placebo
Experimental: Dosing Cohort 8 Drug: REGN1154 or placebo
Participants will receive active drug or placebo

  Eligibility

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

Inclusion Criteria:

  1. Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
  2. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
  3. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
  4. Able to read or to understand the consent process, and willing to sign the informed consent form (ICF)

Exclusion Criteria:

Exclusion criteria include, but are not limited to the following:

  1. Any illness or condition that would adversely affect the subject's participation in this study
  2. Any clinically significant abnormalities observed during the screening visit
  3. Use of certain medications taken before the screening visit
  4. Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit
  5. Hospitalization within 60 days of the screening visit
  6. Any condition that would place the subject at risk, interfere with participation in the study
  7. History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
  8. History of certain other conditions
  9. Positive urine, drug or alcohol screen result at screening
  10. Known sensitivity to any of the components of the investigational product formulation
  11. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
  12. Live/attenuated vaccinations within 12 weeks of screening or during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540539

Locations
Australia
Melbourne, Australia
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01540539     History of Changes
Other Study ID Numbers: R1154-HV-1116
Study First Received: February 23, 2012
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board
Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration

ClinicalTrials.gov processed this record on May 16, 2013