A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Fasinumab in Healthy Japanese and Caucasian Subjects
Overview
- Phase
- Phase 1
- Intervention
- Fasinumab
- Conditions
- Healthy Volunteers
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 72
- Primary Endpoint
- The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with fasinumab or placebo.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or female Japanese and Caucasian volunteers ≥20 and ≤55 years of age at the screening visit
- •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
- •Caucasian subjects must be Caucasian of European or Latin American descent
- •Have a Body Mass Index (BMI) ≤ 35
- •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
Exclusion Criteria
- •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
- •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
- •Trauma to any joint in the 30 days prior to the screening visit
- •History of autonomic neuropathy, or diabetic neuropathy
- •Evidence of autonomic neuropathy
- •Presence of clinically relevant peripheral neuropathy
- •History or presence at the screening visit of orthostatic hypotension
- •History or evidence at screening of heart block
- •Resting heart rate of \<50 or \>100 beats per minute (bpm)
- •History of poorly controlled hypertension:
Arms & Interventions
Cohort 1
Participants in this cohort will receive dose 1 of Fasinumab or placebo
Intervention: Fasinumab
Cohort 1
Participants in this cohort will receive dose 1 of Fasinumab or placebo
Intervention: Placebo
Cohort 2
Participants in this cohort will receive dose 2 of Fasinumab or placebo
Intervention: Fasinumab
Cohort 2
Participants in this cohort will receive dose 2 of Fasinumab or placebo
Intervention: Placebo
Cohort 3
Participants in this cohort will receive dose 3 of Fasinumab or placebo
Intervention: Fasinumab
Cohort 3
Participants in this cohort will receive dose 3 of Fasinumab or placebo
Intervention: Placebo
Cohort 4
Participants in this cohort will receive dose 4 of Fasinumab or placebo
Intervention: Fasinumab
Cohort 4
Participants in this cohort will receive dose 4 of Fasinumab or placebo
Intervention: Placebo
Cohort 5
Participants in this cohort will receive dose 5 of Fasinumab or placebo
Intervention: Fasinumab
Cohort 5
Participants in this cohort will receive dose 5 of Fasinumab or placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- 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))