Trial record 2 of 45 for:    regeneron | Open Studies

Study of Fasinumab (REGN475) in Healthy Japanese and Caucasian Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02516618
First received: July 31, 2015
Last updated: August 3, 2015
Last verified: August 2015
  Purpose

The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) or intravenous (IV) administered fasinumab in healthy Japanese subjects.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Fasinumab in Healthy Japanese and Caucasian Subjects

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with fasinumab or placebo. [ Time Frame: Baseline to week 16 (End of Study) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Fasinumab serum concentrations over time [ Time Frame: Baseline to week 16 (End of Study) ] [ Designated as safety issue: No ]
  • Presence of anti-fasinumab antibodies over time [ Time Frame: Baseline to week 16 (End of Study) ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: July 2015
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Participants in this cohort will receive dose 1 of Fasinumab or placebo
Drug: Fasinumab
Other Name: REGN475
Drug: Placebo
Experimental: Cohort 2
Participants in this cohort will receive dose 2 of Fasinumab or placebo
Drug: Fasinumab
Other Name: REGN475
Drug: Placebo
Experimental: Cohort 3
Participants in this cohort will receive dose 3 of Fasinumab or placebo
Drug: Fasinumab
Other Name: REGN475
Drug: Placebo
Experimental: Cohort 4
Participants in this cohort will receive dose 4 of Fasinumab or placebo
Drug: Fasinumab
Other Name: REGN475
Drug: Placebo
Experimental: Cohort 5
Participants in this cohort will receive dose 5 of Fasinumab or placebo
Drug: Fasinumab
Other Name: REGN475
Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  1. Healthy male or female Japanese and Caucasian volunteers ≥20 and ≤55 years of age at the screening visit
  2. Japanese subjects must:

    • Be first generation Japanese, defined as born in Japan and having 4 biologic grandparents who are ethnic Japanese
    • Have maintained a Japanese lifestyle since leaving Japan
  3. Caucasian subjects must be Caucasian of European or Latin American descent
  4. Have a Body Mass Index (BMI) ≤ 35
  5. Be willing to refrain from taking NSAID medications (oral or topical) for 1 week prior to receiving study drug and for 16 weeks after study drug administration

Key Exclusion Criteria:

  1. History or presence at the screening visit of bone or joint disorders including but not limited to osteoarthritis, avascular necrosis, destructive arthropathy, pathologic fractures, osteonecrosis, rheumatoid arthritis, neuropathic joint arthropathy, lupus erythematosus, or inflammatory joint diseases
  2. History of joint-related events such as, but not limited to, total joint replacement (TJR) surgery, patella dislocation, hip dislocation, knee dislocation, injury to meniscus or knee ligaments (with or without surgical repair), or joint infections
  3. Trauma to any joint in the 30 days prior to the screening visit
  4. History of autonomic neuropathy, or diabetic neuropathy
  5. Evidence of autonomic neuropathy
  6. Presence of clinically relevant peripheral neuropathy
  7. History or presence at the screening visit of orthostatic hypotension
  8. History or evidence at screening of heart block
  9. Resting heart rate of <50 or >100 beats per minute (bpm)
  10. History of poorly controlled hypertension:
  11. Congestive heart failure with NY Heart Classification of stage 3 or 4
  12. History of myocardial infarction, acute coronary syndromes, or cerebrovascular accident within 12 months prior to the screening visit
  13. Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, GI, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/PK data
  14. HIV, hepatitis B, or hepatitis C positive by serological testing at the screening visit
  15. History or presence of malignancy within 5 years prior to screening, except subjects who have been treated successfully with no recurrence of basal or squamous cell carcinoma of the skin (< 1 year), in situ cervical cancer, or in situ ductal breast cancer
  16. Women of reproductive potential who have a positive serum pregnancy test result at the screening visit, or a positive urine pregnancy test result at the baseline visit, or who do not have their pregnancy test results at the baseline visit
  17. Pregnant or breast-feeding women
  18. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives of the investigational drug, whichever is longer, prior to the day 1 visit
  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: NCT02516618

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, California
Recruiting
Glendale, California, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02516618     History of Changes
Other Study ID Numbers: R475-PN-1516
Study First Received: July 31, 2015
Last Updated: August 3, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 27, 2015