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Study of Safety, Tolerability, and Pharmacokinetics of REGN3470-3471-3479 in Healthy Adult Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02777151
First received: May 17, 2016
Last updated: June 23, 2016
Last verified: June 2016
  Purpose
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and immunogenicity of REGN3470-3471-3479 in healthy adult volunteers.

Condition Intervention Phase
Healthy Volunteers
Drug: REGN3470-3471-3479
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)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered REGN3470-3471-3479 in Healthy Adult Subjects

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Incidence and severity of TEAEs through the end of the study visit in subjects treated with REGN3470-3471-3479 in a fixed dose combination [ Time Frame: From baseline up to day 169 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Concentration of REGN3479 in serum over time [ Time Frame: From baseline up to day 169 ] [ Designated as safety issue: No ]
  • Concentration of REGN3471 in serum over time [ Time Frame: From baseline up to day 169 ] [ Designated as safety issue: No ]
  • Concentration of REGN3470 in serum over time [ Time Frame: From baseline up to day 169 ] [ Designated as safety issue: No ]
  • The presence or absence of antibodies against REGN3470 over time [ Time Frame: From baseline up to day 169 ] [ Designated as safety issue: No ]
  • The presence or absence of antibodies against REGN3471 over time [ Time Frame: From baseline up to day 169 ] [ Designated as safety issue: No ]
  • The presence or absence of antibodies against REGN3479 over time [ Time Frame: From baseline up to day 169 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
REGN3470-3471-3479 dosing level 1 or placebo
Drug: REGN3470-3471-3479 Drug: Placebo
Experimental: Cohort 2
REGN3470-3471-3479 dosing level 2 or placebo
Drug: REGN3470-3471-3479 Drug: Placebo
Experimental: Cohort 3
REGN3470-3471-3479 dosing level 3 or placebo
Drug: REGN3470-3471-3479 Drug: Placebo
Experimental: Cohort 4
REGN3470-3471-3479 dosing level 4 or placebo
Drug: REGN3470-3471-3479 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy man or woman between the ages of 18 and 60
  2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive
  3. Willing and able to comply with clinic visits and study-related procedures
  4. Provide signed informed consent
  5. Able to understand and complete study-related questionnaires

Exclusion Criteria:

  1. Use of any medications started within 30 days prior to the screening visit including, prescription medications, nutritional supplements, and over-the-counter medications except for vitamin supplements, and recommended doses of acetaminophen, aspirin or ibuprofen
  2. Hospitalization for any reason within 60 days prior to the screening visit
  3. History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
  4. History of or positive blood test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody at the screening visit
  5. History of drug or alcohol abuse within 1 year prior to screening
  6. Participation in any clinical research study evaluating 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
  7. Any history of receiving treatment, vaccine or mAbs against the Ebola virus
  8. Pregnant or breast-feeding women
  9. Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

    • Contraception is not required for men with documented vasectomy.
    • Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. A baseline follicle-stimulating hormone (FSH) test will be performed for confirmation of menopausal status. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
  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: NCT02777151

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, Indiana
Recruiting
Evansville, Indiana, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Department of Health and Human Services
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02777151     History of Changes
Other Study ID Numbers: R3470-3471-3479-HV-1528 
Study First Received: May 17, 2016
Last Updated: June 23, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on September 23, 2016