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Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1500 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT02107872•Regeneron Pharmaceuticals

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (4)

Daytona Beach, Florida, United States

Evansville, Indiana, United States

Dallas, Texas, United States

San Antonio, Texas, United States

Key Dates

Start Date

April 1, 2014

Primary Completion Date

September 1, 2015

Completion Date

September 1, 2015

Last Updated

September 30, 2015

Enrollment

ACTUAL participants

Conditions

Metabolic Disorders

Interventions

REGN1500

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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