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Study to Assess the Safety and Tolerability of Single Doses of REGN1500

This study is currently recruiting participants.
Verified December 2012 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01749878
First received: December 12, 2012
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

Phase 1, first-in-human, randomized, ascending single-dose, placebo-controlled, double-blind study of the safety, tolerability, and bioeffect of REGN1500


Condition Intervention Phase
Healthy Volunteers
 Drug: REGN1500
Drug: 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:
  • Safety [ Time Frame: Day 1 to Day 106 ] [ Designated as safety issue: Yes ]
    The primary endpoint in the study is the incidence and severity of treatment-emergent adverse events (TEAEs) through day 106 in participants treated with REGN1500.


Secondary Outcome Measures:
  • Serum concentration of REGN1500 [ Time Frame: Day 1 to Day 106 ] [ Designated as safety issue: No ]
    Serum concentration of REGN1500 over time (summary statistics and PK parameters)


Estimated Enrollment: 80
Study Start Date: December 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Subcutaneous (SC) injection of REGN1500 (Dose 1) or placebo SC
 Drug: REGN1500 Drug: Placebo
Experimental: Cohort 2
SC injection of REGN1500 (Dose 2) or placebo SC
 Drug: REGN1500 Drug: Placebo
Experimental: Cohort 3
SC injection of REGN1500 (Dose 3) or placebo SC
 Drug: REGN1500 Drug: Placebo
Experimental: Cohort 4
Intravenous (IV) infusion of REGN1500 (Dose 4) or placebo IV
 Drug: REGN1500 Drug: Placebo
Experimental: Cohort 5
IV infusion of REGN1500 (Dose 5) or placebo IV
 Drug: REGN1500 Drug: Placebo

  Eligibility

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

Inclusion Criteria:

  1. Body mass index 18.0 to 35.0 kg/m2, inclusive
  2. Normal standard 12-lead ECG
  3. Willing to refrain from the consumption of alcohol for 24 hours prior to each study visit
  4. Willing to consistently maintain his/her usual diet for the duration of the study
  5. Willing to refrain from strenuous exercise for the duration of the trial
  6. Willing and able to comply with clinic visits and study-related procedures
  7. Provide signed informed consent
  8. For sexually active 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.

Exclusion Criteria:

  1. Any clinically significant abnormalities observed during the screening visit
  2. History of drug, or alcohol abuse, or cigarette smoking within 1 year of screening
  3. 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.
  4. 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 may adversely affect the subjects participation in this study
  5. Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen (HBsAg), and/or positive hepatitis C antibody (HCV) at the screening visit
  6. Hospitalization for any reason within 60 days of screening
  7. History or presence of malignancy within 5 years prior to the screening visit (other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, and/or localized carcinoma in situ of the cervix
  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. Any subject who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved in the conduct of the protocol, or family member of staff involved in the conduct of the protocol
  10. Pregnant or breast-feeding women

(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749878

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, Florida
Recruiting
Miramar, Florida, 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: NCT01749878     History of Changes
Other Study ID Numbers: R1500-HV-1214
Study First Received: December 12, 2012
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013