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OpenTrials
Completed

NCT Number: NCT02107872

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REGN1500

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 8, 2014
Registry last updated
Sep 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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