A Multicenter, Randomized, Double-Blind, Placebo-Controlled, MAD Study to Evaluation of Safety, Tolerability and PK of SHR1314 With Axial Spondyloarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The safety and tolerability of multiple subcutaneous injections of SHR1314 in adult patients with axial spondyloarthritis 1.Incidence of Treatment-Emergent Adverse Events 2.Incidence of Injection site reaction
研究概览
简要总结
The main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics (PK) of SHR1314 with axial spondyloarthritis.
详细描述
This was a phase I, multicenter, double-blind, randomized, placebo-controlled study. The study originally planned to enroll 5 cohorts of 8 subjects each (N=40).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of axial spondyloarthritis (axSpA) and fulfilling the 2009 ASAS classification criteria.
- •Have a history of back pain ≥3 months with age at onset <45 years.
- •Have active axSpA defined as BASDAI ≥4 at screening and baseline.
- •Have objective signs of inflammation by presence of elevated ESR and/or presence of elevated CRP.
- •In the past had an inadequate response to at least 1 or 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
- •If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.
排除标准
- •History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
- •Previous exposure to other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.
- •Total ankylosis of the spine.
- •Have recently received biologics, tumor necrosis factor inhibitors or other immunomodulatory agents within 12 weeks.
- •Have either a current diagnosis or a recent history of malignant disease.
- •Are pregnant or breastfeeding.
研究组 & 干预措施
Cohort 1
Multiple subcutaneous injections of SHR-1314 dose 1
干预措施: SHR-1314 (Drug)
Cohort 2
Multiple subcutaneous injections of SHR-1314 dose 2
干预措施: SHR-1314 (Drug)
Cohort 3
Multiple subcutaneous injections of SHR-1314 dose 3
干预措施: SHR-1314 (Drug)
Cohort 4
Multiple subcutaneous injections of SHR-1314 dose 4
干预措施: SHR-1314 (Drug)
Cohort 5
Multiple subcutaneous injections of SHR-1314 dose 5
干预措施: SHR-1314 (Drug)
结局指标
主要结局
The safety and tolerability of multiple subcutaneous injections of SHR1314 in adult patients with axial spondyloarthritis 1.Incidence of Treatment-Emergent Adverse Events 2.Incidence of Injection site reaction
时间窗: Baseline to 169 days after dose administration
Safety and tolerability of multiple subcutaneous injections of SHR1314 assessed by adverse events and serious adverse events. 1. Incidence of Treatment-Emergent Adverse Events 2. Incidence of Injection site reaction
次要结局
- Time to elimination half-life (t1/2) of SHR-1314(Baseline to 169 days after dose administration)
- Proportion of Participants Achieving an ASAS20 Response(Week2, 4, 6, 8, 12,16)
- Time to maximum observed serum concentration (tmax) of SHR-1314(Baseline to 169 days after dose administration)
- Maximum observed serum concentration (Cmax) of SHR-1314(Baseline to 169 days after dose administration)
- Assessment of development of Anti-drug Antibodies (ADAs)(Baseline to 169 days after dose administration)