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Completed

NCT Number: NCT02958436

A Study of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects

The primary objective of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and females

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site 1

Ghent, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index</= 33 kg/m2
  • In good health based on medical history, physical examination, vital signs, and laboratory testing
  • Normal electrocardiogram (ECG) and blood pressure
  • Able to comply with clinic visits and study-related procedures
  • Able to sign an informed consent

Exclusion criteria

  • Significant abnormalities in hematology, clinical chemistry, urinalysis, medical history
  • Current smoker or recent history (within 3 months)
  • History of tuberculosis, HIV, or hepatic disease
  • Known sensitivity to doxycycline or other ingredients of study drug
  • History of multiple/severe allergies
  • Pregnant or breastfeeding women, or not currently using adequate contraception
  • Participation in another investigational drug study within 4 weeks

Treatment and study plan

REGN3500

Drug

Placebo

Drug

Primary outcomes

  1. The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500

    Time frame: Up to 293 days after dosing

Secondary outcomes

  1. Obtain the pharmacokinetic parameters (Cmax) that describe the serum concentration time profile of REGN3500

    Time frame: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing

  2. Obtain the pharmacokinetic parameters (Tmax) that describe the serum concentration time profile of REGN3500

    Time frame: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing

  3. Obtain the pharmacokinetic parameters (AUClast) that describe the serum concentration time profile of REGN3500

    Time frame: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2016
Registry last updated
Nov 8, 2017

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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