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OpenTrials
Completed

NCT Number: NCT02828397

Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy Subjects

Primary Objective: Determine blood concentrations of two formulations of REGN2222

Secondary Objective: Assess safety and tolerability of REGN2222

Completed

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Daytona Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Healthy man or woman aged 18 to 60 years
  • Body weight between 50.0 kg and 95.0 kg, inclusive
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

Key Exclusion Criteria:

  • Hemoglobin not within normal limits
  • Positive drug and alcohol screen test results at screening visits 1 and 2
  • 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
  • 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

REGN2222

Drug

Primary outcomes

  1. Serum REGN2222 concentration-time curve (AUC)

    Time frame: Day 1 to Day 148 (end of study)

  2. Peak REGN2222 concentration (Cmax)

    Time frame: Day 1 to Day 148 (end of study)

Secondary outcomes

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

    Time frame: Day 1 to Day 148 (end of study)

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

    Time frame: Day 1 to Day 148 (end of study)

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 Intramuscular (IM) Injection of REGN2222 Produced by 2 Different Cell Lines in Healthy Adult Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2016
Registry last updated
Nov 4, 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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