Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1500
NCT ID: NCT02107872
Last Updated: 2015-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
55 participants
INTERVENTIONAL
2014-04-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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dosing cohort 1
Patients will receive REGN1500 or placebo in dosing cohort 1
REGN1500
placebo
dosing cohort 2
Patients will receive REGN1500 or placebo in dosing cohort 2
REGN1500
placebo
dosing cohort 3
Patients will receive REGN1500 or placebo in dosing cohort 3
REGN1500
placebo
dosing cohort 4
Patients will receive REGN1500 or placebo in dosing cohort 4
REGN1500
placebo
dosing cohort 5
Patients will receive REGN1500 or placebo in dosing cohort 5
REGN1500
placebo
Interventions
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REGN1500
placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Daytona Beach, Florida, United States
Evansville, Indiana, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Countries
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References
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Ahmad Z, Banerjee P, Hamon S, Chan KC, Bouzelmat A, Sasiela WJ, Pordy R, Mellis S, Dansky H, Gipe DA, Dunbar RL. Inhibition of Angiopoietin-Like Protein 3 With a Monoclonal Antibody Reduces Triglycerides in Hypertriglyceridemia. Circulation. 2019 Aug 6;140(6):470-486. doi: 10.1161/CIRCULATIONAHA.118.039107. Epub 2019 Jun 27.
Other Identifiers
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R1500-CL-1321
Identifier Type: -
Identifier Source: org_study_id