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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01749878
First received: December 12, 2012
Last updated: March 24, 2014
Last verified: March 2014
  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 106/126 ] [ Designated as safety issue: Yes ]
    The primary endpoint in the study is the incidence and severity of treatment-emergent adverse events (TEAEs) through day 106/126 in participants treated with REGN1500.


Secondary Outcome Measures:
  • Serum concentration of REGN1500 [ Time Frame: Day 1 to Day 106/126 ] [ Designated as safety issue: No ]
    Serum concentration of REGN1500 over time (summary statistics and PK parameters)


Estimated Enrollment: 96
Study Start Date: December 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (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
Experimental: Cohort 6
IV infusion of REGN1500 (Dose 6) 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 40.0 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 within 1 year of screening
  3. Receipt of 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
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: NCT01749878

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, Florida
Withdrawn
Miramar, Florida, United States
United States, Kansas
Recruiting
Overland Park, Kansas, United States
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, 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: March 24, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014