A Phase 1, Randomized, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose Study of FPA008 in Healthy Volunteers and Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Incidence of adverse events and dose-limiting toxicities of FPA008 administered in healthy volunteers and RA subjects
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled study designed in 3 parts to assess the safety, tolerability, and PK of single and multiple ascending doses of FPA008 in adult healthy volunteers (Parts 1 and 2) and adult subjects with active RA (Part 3).
详细描述
Approximately 56 healthy volunteers will be enrolled at 1 study center in the Netherlands for Parts 1 and 2, and approximately 39 subjects will be enrolled at up to 6 sites in Central and Eastern Europe for Part 3. Dose escalations in Parts 1 and 2 will be driven by an assessment of the safety profile. Review of safety and PK parameters may inform decisions to add cohorts with intermediate dose levels in order to reach an optimal target exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part 1 and 2:
- •Healthy adult male and female subjects between the ages of 21-55 years inclusive.
- •Subject must be willing to remain in the Clinical Research Unit (CRU) for a minimum of 72 hours after each dose.
- •RA male and female subjects between the ages of 21-70 years inclusive
- •Evidence of active RA disease
- •Inadequate response to biologic or non-biologic DMARDs
- •Subjects will be required to be on background therapy with methotrexate.
排除标准
- •Parts 1, 2 and 3:
- •BMI <18 or >32 kg/m2
- •Clinically significant findings in physical exams and laboratory tests at screening and/or baseline
- •Unwilling to abstain from alcohol for 48 hours prior to study start, during CRU confinement, as applicable, and for 48 hours prior to study visits.
- •Unwilling to abstain from exercise more strenuous than walking during CRU confinement, as applicable, and for 48 hours prior to study visits.
- •Parts 1 and 2:
- •Use of any prescription, non-prescription, or herbal medications as well as supplements or vitamins within 4 weeks prior to dosing, unless approved by the Investigator.
- •Smoking more than 10 cigarettes, or the equivalent, per day.
- •Current or previous history of inflammatory joint disease other than RA
- •Evidence of extra-articular RA disease or systemic involvement
- •Currently taking any medications other than those allowed per protocol guidelines
- •Any surgical procedure including bone or joint surgery within 12 weeks prior to dosing
- •Use of intra-articular (IA), intramuscular (IM), or IV corticosteroids for RA
- •Neuropathies and neurovasculopathies
- •Concomitant use of statins while on study.
研究组 & 干预措施
1-FPA008/Placebo Randomize DoseLevels1-4
Single infusion at 4 different dose levels
干预措施: FPA008 (Drug)
1-FPA008/Placebo Randomize DoseLevels1-4
Single infusion at 4 different dose levels
干预措施: Placebo (Drug)
2-FPA008/Placebo Randomize DoseLevels1-2
Dual Infusions at 2 different dose levels
干预措施: FPA008 (Drug)
2-FPA008/Placebo Randomize DoseLevels1-2
Dual Infusions at 2 different dose levels
干预措施: Placebo (Drug)
3-FPA008 Open-Label DoseLevels 1-3
Dual infusions at 1 dose level AND Dual/Triple infusions at 2 different dose levels
干预措施: FPA008 (Drug)
结局指标
主要结局
Incidence of adverse events and dose-limiting toxicities of FPA008 administered in healthy volunteers and RA subjects
时间窗: within 4-12 weeks
Incidence of all-grade adverse events and dose limiting toxicities (DLT) during the DLT observation period and/or study treatment periods
次要结局
未报告次要终点