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OpenTrials
Completed

NCT Number: NCT01933763

An Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of REGN1193

Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy volunteers.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dallas, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men and women 18 to 45 years of age (inclusive)
  • Body mass index 18.0 to 30.0 kg/m^2 (inclusive)
  • Normal standard 12-lead ECG
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent
  • 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 and for up to 3 months after participation in the study.

Exclusion criteria

  • Any clinically significant abnormalities or other characteristics that would preclude the subject from safely enrolling or successfully completing the study
  • History of drug or alcohol abuse within a year prior to the screening visit
  • Current regular smoking, or a history of smoking greater than ½ pack
  • Receipt of an investigational drug within 30 days of screening, or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
  • 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 subject's 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 (including carcinoma in situ) prior to the screening visit
  • 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

(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).

Treatment and study plan

REGN1193

Drug

Placebo

Other

Primary outcomes

  1. Number of TEAEs

    Time frame: day 1 to day 106

    The primary endpoint in this study is the incidence and severity of TEAEs (treatment emergent adverse events) in healthy volunteers treated with REGN1193 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 16.

Secondary outcomes

  1. Serum concentration

    Time frame: day 1 to day 106

    Serum concentrations of REGN1193 over time

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 2, 2013
Registry last updated
Mar 13, 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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