Trial record 3 of 47 for:    regeneron | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01893528
First received: June 21, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: REGN2009
Other: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Number of TEAEs [ Time Frame: day 1 to day 106/ visit 15 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 48
Study Start Date: June 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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.

  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: NCT01893528

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, Maryland
Recruiting
Baltimore, Maryland, United States
United States, Ohio
Recruiting
Cincinnati, Ohio, United States
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: NCT01893528     History of Changes
Other Study ID Numbers: R2009-HV-1304
Study First Received: June 21, 2013
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 26, 2014