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OpenTrials
Completed

NCT Number: NCT02741739

Study of the Blood Concentrations of Two Formulations of REGN1033 in Healthy Subjects

Primary Objective: Determine blood concentrations of two formulations of REGN1033.

Secondary Objective: Assess safety and tolerability of REGN1033.

Completed

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

San Antonio, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Healthy males and females (not of childbearing potential) between the ages of 18 and 65 years
  • Body weight between 50.0 kg and 95.0 kg
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

Key Exclusion Criteria:

  • Donation or loss of approximately 400 mL or more of blood within 8 weeks prior to dosing, or plasma up to 14 days prior to dosing
  • Hemoglobin not within normal limits
  • Positive drug and alcohol screen test results at screening visits 1 and 2
  • Low or elevated blood pressure and/or heart rate after 3 minutes resting in the seated position:
  • Recent use (within 3 months prior to screening) of androgenic steroids
  • Participation in any clinical research study that evaluated 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
  • Previous exposure to any biological therapeutic agent, except vaccines
  • Known sensitivity to tamoxifen, doxycycline, or similar compounds (ie, tetracyclines)
  • Pregnant or breastfeeding women, and women of childbearing potential
  • Sexually active men who are unwilling to practice adequate contraception during the study

Treatment and study plan

REGN1033

Drug

Primary outcomes

  1. Serum REGN1033 concentration-time curve (AUC)

    Time frame: Pre-dose to day 57

  2. Peak REGN1033 concentration (Cmax)

    Time frame: Pre-dose to day 57

Secondary outcomes

  1. Treatment-emergent adverse events (TEAEs) from baseline to the end of the study

    Time frame: Day 1 to end of study (Day 57)

  2. Presence or absence of anti-drug antibody (ADA)

    Time frame: Day 1 to end of study (Day 57)

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of REGN1033 Produced From Two Different Cell Lines in Healthy Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 18, 2016
Registry last updated
Oct 14, 2016

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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