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

This study has been completed.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals Identifier:
First received: December 12, 2012
Last updated: May 10, 2016
Last verified: May 2016
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
Hypertriglyceridemia Drug: REGN1500 Drug: placebo Phase 1

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

Resource links provided by NLM:

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Safety [ Time Frame: Day 1 to Day 106/126 ]
    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 ]
    Serum concentration of REGN1500 over time (summary statistics and PK parameters)

Enrollment: 99
Study Start Date: December 2012
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: Cohorts 1 through 6

Group A:

Cohorts 1 through 3 will receive REGN1500 subcutaneous (SC) or placebo Cohorts 4 through 6 will receive REGN1500 intravenous (IV) or placebo

Drug: REGN1500 Drug: placebo
Experimental: Group B
Group B will receive REGN1500 IV or placebo
Drug: REGN1500 Drug: placebo
Experimental: Group C: Cohorts 1 and 2

Group C:

Cohort 1 will receive REGN1500 SC or placebo Cohort 2 will receive REGN1500 IV or placebo

Drug: REGN1500 Drug: placebo


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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, willingness to utilize adequate contraception and not 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 identifier: NCT01749878

United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT01749878     History of Changes
Other Study ID Numbers: R1500-HV-1214
Study First Received: December 12, 2012
Last Updated: May 10, 2016

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases processed this record on June 23, 2017