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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01893528
Collaborator
(none)
49
Enrollment
2
Locations
3
Arms
15
Duration (Months)
24.5
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of TEAEs [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Healthy men and women ages 18 to 65 years inclusive

  2. Body mass index between 18.0 kg/m2 and 30.0 kg/m2, 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baltimore Maryland United States
2 Cincinnati Ohio United States

Sponsors and Collaborators

  • Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01893528
Other Study ID Numbers:
  • R2009-HV-1304
First Posted:
Jul 9, 2013
Last Update Posted:
Nov 10, 2014
Last Verified:
Nov 1, 2014

Study Results

No Results Posted as of Nov 10, 2014