Trial record 2 of 45 for:    regeneron | Open Studies

Study of the Safety and Tolerability of REGN2222(SAR438584) in Healthy Adult Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02121080
First received: April 21, 2014
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

This is a phase 1, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetic (PK) profile, and immunogenicity of REGN2222 ascending in cohorts of healthy adult volunteers.


Condition Intervention Phase
Healthy Volunteers
Drug: REGN2222(SAR438584)
Drug: placebo
Phase 1

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

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Safety [ Time Frame: from day 1 up to week 20 (EOS) ] [ Designated as safety issue: Yes ]
    The primary endpoint in the study is the incidence and severity of treatment-emergent adverse events (TEAEs) from day 1 through the end of study (EOS/ up to 20 weeks) in participants treated with REGN2222 or placebo.


Secondary Outcome Measures:
  • Serum concentration [ Time Frame: from day 1 over time up to week 20 ] [ Designated as safety issue: No ]
    Serum concentration of REGN2222 over time up to week 20

  • Presence or absence of antibodies [ Time Frame: from day 1 over time up to week 20 ] [ Designated as safety issue: No ]
    The presence or absence of antibodies against REGN2222 over time up to week 20


Estimated Enrollment: 132
Study Start Date: May 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Dosing regimen 1
Drug: REGN2222(SAR438584) Drug: placebo
Experimental: Cohort 2
Dosing regimen 2
Drug: REGN2222(SAR438584) Drug: placebo
Experimental: Cohort 3
Dosing regimen 3
Drug: REGN2222(SAR438584) Drug: placebo
Experimental: Cohort 4
Dosing regimen 4
Drug: REGN2222(SAR438584) Drug: placebo
Experimental: Cohort 5
Dosing regimen 5
Drug: REGN2222(SAR438584) Drug: placebo

  Eligibility

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

Inclusion Criteria:

  1. A healthy man or woman aged 18 to 60 years
  2. Body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive
  3. Willing and able to comply with clinic visits and study-related procedures
  4. Provide signed informed consent

Exclusion Criteria:

  1. Serum hemoglobin, creatinine, alkaline phosphatase, CPK, and/or hepatic enzymes (aspartate aminotransferase [AST] and alanine aminotransferase [ALT], total bilirubin [unless the investigator has evidence that increased bilirubin corresponds to a Gilbert's type syndrome with elevated indirect bilirubin]) that is >1.5 the upper limit of normal (ULN), or any laboratory findings showing evidence of organ dysfunction or any clinically significant abnormalities from the normal range, as determined by the investigator at the screening visit
  2. Use of any concomitant medications within 30 days or at least 5 half-lives, whichever is longer, of the screening visit, including prescription medications (except contraceptives), nutritional supplements, and over-the-counter medications (except acetaminophen)
  3. Hospitalization for any reason within 60 days of the screening visit
  4. History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
  5. History of or positive blood test result for hepatitis B surface antigen and/or hepatitis C virus antibody at the screening visit
  6. History of autoimmune disease
  7. History of respiratory disease (e.g, asthma, chronic obstructive pulmonary disease)
  8. History of drug or alcohol abuse within 1 year prior to the screening visit
  9. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days, or within at least 5 half-lives, of the investigational drug (whichever is longer) prior to the screening visit
  10. Pregnant or breastfeeding woman
  11. Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study, and up to 3 months after the last dose of the study drug (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; 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. Contraception is 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: NCT02121080

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, Florida
Recruiting
Daytona Beach, Florida, United States
United States, Indiana
Recruiting
Evansville, Indiana, United States
United States, Texas
Recruiting
Dallas, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02121080     History of Changes
Other Study ID Numbers: R2222-HV-1326
Study First Received: April 21, 2014
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014