A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Fasinumab in Healthy Japanese and Caucasian Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with fasinumab or placebo.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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:
- •Congestive heart failure with NY Heart Classification of stage 3 or 4
- •History of myocardial infarction, acute coronary syndromes, or cerebrovascular accident within 12 months prior to the screening visit
- •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
- •HIV, hepatitis B, or hepatitis C positive by serological testing at the screening visit
- •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
- •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
- •Pregnant or breast-feeding women
- •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
研究组 & 干预措施
Cohort 1
Participants in this cohort will receive dose 1 of Fasinumab or placebo
干预措施: Fasinumab (Drug)
Cohort 1
Participants in this cohort will receive dose 1 of Fasinumab or placebo
干预措施: Placebo (Drug)
Cohort 2
Participants in this cohort will receive dose 2 of Fasinumab or placebo
干预措施: Fasinumab (Drug)
Cohort 2
Participants in this cohort will receive dose 2 of Fasinumab or placebo
干预措施: Placebo (Drug)
Cohort 3
Participants in this cohort will receive dose 3 of Fasinumab or placebo
干预措施: Fasinumab (Drug)
Cohort 3
Participants in this cohort will receive dose 3 of Fasinumab or placebo
干预措施: Placebo (Drug)
Cohort 4
Participants in this cohort will receive dose 4 of Fasinumab or placebo
干预措施: Fasinumab (Drug)
Cohort 4
Participants in this cohort will receive dose 4 of Fasinumab or placebo
干预措施: Placebo (Drug)
Cohort 5
Participants in this cohort will receive dose 5 of Fasinumab or placebo
干预措施: Fasinumab (Drug)
Cohort 5
Participants in this cohort will receive dose 5 of Fasinumab or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with fasinumab or placebo.
时间窗: Baseline to week 16 (End of Study)
次要结局
- 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))