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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02958436
First received: October 25, 2016
Last updated: November 4, 2016
Last verified: November 2016
  Purpose
The primary object 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

Condition Intervention Phase
Healthy Volunteers
Drug: REGN3500
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official 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

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500 [ Time Frame: Up to 113 days (16 weeks) after dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 31
Study Start Date: August 2016
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Dose regimen 1 of REGN3500 (IV) versus placebo
Drug: REGN3500 Drug: Placebo
Experimental: Cohort 2
Dose regimen 2 of REGN3500 (IV) versus placebo
Drug: REGN3500 Drug: Placebo
Experimental: Cohort 3
Dose regimen 3 of REGN3500 (IV) versus placebo
Drug: REGN3500 Drug: Placebo
Experimental: Cohort 4
Dose regimen 4 of REGN3500 (SC) versus placebo
Drug: REGN3500 Drug: Placebo
Experimental: Cohort 5
Dose regimen 5 of REGN3500 (IV) versus placebo
Drug: REGN3500 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02958436

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
Belgium
Site 1 Recruiting
Ghent, Belgium
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02958436     History of Changes
Other Study ID Numbers: R3500-HV-1551  2016-002012-41 
Study First Received: October 25, 2016
Last Updated: November 4, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Regeneron Pharmaceuticals:
Safety
Tolerability
Pharmacokinetics
REGN3500

ClinicalTrials.gov processed this record on December 02, 2016