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Study to Assess the Safety and Tolerability of Single 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: NCT01749878
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016
Arms and Interventions
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Arm Intervention/treatment
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


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


Eligibility Criteria
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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:   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, 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
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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): NCT01749878


Locations
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United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Dewey FE, Gusarova V, Dunbar RL, O'Dushlaine C, Schurmann C, Gottesman O, McCarthy S, Van Hout CV, Bruse S, Dansky HM, Leader JB, Murray MF, Ritchie MD, Kirchner HL, Habegger L, Lopez A, Penn J, Zhao A, Shao W, Stahl N, Murphy AJ, Hamon S, Bouzelmat A, Zhang R, Shumel B, Pordy R, Gipe D, Herman GA, Sheu WHH, Lee IT, Liang KW, Guo X, Rotter JI, Chen YI, Kraus WE, Shah SH, Damrauer S, Small A, Rader DJ, Wulff AB, Nordestgaard BG, Tybjærg-Hansen A, van den Hoek AM, Princen HMG, Ledbetter DH, Carey DJ, Overton JD, Reid JG, Sasiela WJ, Banerjee P, Shuldiner AR, Borecki IB, Teslovich TM, Yancopoulos GD, Mellis SJ, Gromada J, Baras A. Genetic and Pharmacologic Inactivation of ANGPTL3 and Cardiovascular Disease. N Engl J Med. 2017 Jul 20;377(3):211-221. doi: 10.1056/NEJMoa1612790. Epub 2017 May 24.

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01749878    
Other Study ID Numbers: R1500-HV-1214
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases