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

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Fasinumab in Healthy Japanese and Caucasian Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: Fasinumab

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Participants in this cohort will receive dose 1 of Fasinumab or placebo	Drug: Placebo; Drug: Fasinumab; Other Names: REGN475
Experimental: Cohort 2; Participants in this cohort will receive dose 2 of Fasinumab or placebo	Drug: Placebo; Drug: Fasinumab; Other Names: REGN475
Experimental: Cohort 3; Participants in this cohort will receive dose 3 of Fasinumab or placebo	Drug: Placebo; Drug: Fasinumab; Other Names: REGN475
Experimental: Cohort 4; Participants in this cohort will receive dose 4 of Fasinumab or placebo	Drug: Placebo; Drug: Fasinumab; Other Names: REGN475
Experimental: Cohort 5; Participants in this cohort will receive dose 5 of Fasinumab or placebo	Drug: Placebo; Drug: Fasinumab; Other Names: REGN475

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with fasinumab or placebo.	Baseline to week 16 (End of Study)

Secondary Outcome Measures

Outcome Measure	Time Frame
Fasinumab serum concentrations over time	Baseline to week 16 (End of Study)
Presence of anti-fasinumab antibodies over time	Baseline to week 16 (End of Study)

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: August 3, 2015
• First Posted (Estimate): August 6, 2015

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Fasinumab
• Other Study ID Numbers: R475-PN-1516