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Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1500

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02107872
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) effects of REGN1500 in patients with a metabolic disorder.

Condition or disease Intervention/treatment Phase
Metabolic Disorders Drug: REGN1500 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dosing cohort 1
Patients will receive REGN1500 or placebo in dosing cohort 1
Drug: REGN1500
Drug: placebo
Experimental: dosing cohort 2
Patients will receive REGN1500 or placebo in dosing cohort 2
Drug: REGN1500
Drug: placebo
Experimental: dosing cohort 3
Patients will receive REGN1500 or placebo in dosing cohort 3
Drug: REGN1500
Drug: placebo
Experimental: dosing cohort 4
Patients will receive REGN1500 or placebo in dosing cohort 4
Drug: REGN1500
Drug: placebo
Experimental: dosing cohort 5
Patients will receive REGN1500 or placebo in dosing cohort 5
Drug: REGN1500
Drug: placebo



Primary Outcome Measures :
  1. Safety [ Time Frame: visit 1 to day 183 (EOS) ]
    Safety of REGN1500 will be assessed by physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations from visit 1 to day 183 [EOS (end of study)]


Secondary Outcome Measures :
  1. Serum concentration [ Time Frame: visit 1 to day 183 ]
    Serum concentration, amount of REGN1500 in the circulation, over time (visit 1 to day 183)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide signed informed consent
  • Otherwise healthy men and women ages 18 to 65 years, inclusive
  • Body mass index of 18.0 kg/m2to 38.0 kg/m2, inclusive
  • Normal standard 12-lead ECG
  • Willing to refrain from the consumption of alcohol for 24 hours prior to each study visit
  • Willing to consistently maintain his/her usual diet for the duration of the study
  • Willing to refrain from strenuous exercise for the duration of the trial
  • Willing and able to comply with clinic visits and study-related procedures
  • 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:

  • Any clinically significant abnormalities observed during the screening visit
  • History of drug or alcohol abuse within 1 year of screening
  • 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.
  • 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
  • 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
  • Hospitalization for any reason within 60 days of screening
  • 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
  • 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
  • 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
  • Pregnant or breast-feeding women

Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial and not all inclusion/ exclusion criteria are listed.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107872


Locations
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United States, Florida
Daytona Beach, Florida, United States
United States, Indiana
Evansville, Indiana, United States
United States, Texas
Dallas, Texas, United States
San Antonio, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02107872    
Other Study ID Numbers: R1500-CL-1321
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Metabolic Diseases