A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Injection or Intravenous Infusion of SHR-7590 Injection in Healthy Chinese Participants and Participants With Moderate-to-Severe Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Serious adverse events
研究概览
简要总结
This Phase I first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-7590 via subcutaneous or intravenous administration in Chinese healthy participants and patients with moderate-to-severe inflammatory bowel disease.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily signed the informed consent form
- •Age from 18 to 55 years old
- •Body weight ≥45 kg, body mass index (BMI) 18-26 kg/m2
- •Normal or clinically insignificant vital signs, physical examination, laboratory examination and other examinations
- •Adopt efficient contraceptive measures
排除标准
- •Suspected allergy to the study drug or any component of the study drug
- •Any clinical disease or any other disease that could interfere with the test results
- •Had a history of malignant tumor
- •Had an opportunistic infection within 6 months before screening
- •Acute infection with constitutional symptoms within 4 weeks before baseline
- •Participants who participated in any drug or device clinical trial within 3 months before screening
- •Use of any drug within 1 month before the use of the investigational drug
- •Patients who had used immunosuppressant or anti-interleukin antibody drugs within 6 months before screening
- •Had major trauma or major surgery within 6 months before screening, or were scheduled to undergo surgery during the trial
- •History of blood donation within 1 month before screening, or severe blood loss
研究组 & 干预措施
Dose Level：C
Subject will receive SHR-7590 at dose level C. Subject will receive placebo at dose level C.
干预措施: SHR-7590 (Drug)
Dose Level：C
Subject will receive SHR-7590 at dose level C. Subject will receive placebo at dose level C.
干预措施: Placebo (Drug)
Dose Level：D
Subject will receive SHR-7590 at dose level D. Subject will receive placebo at dose level D.
干预措施: SHR-7590 (Drug)
Dose Level：D
Subject will receive SHR-7590 at dose level D. Subject will receive placebo at dose level D.
干预措施: Placebo (Drug)
Dose Level：E
Subject will receive SHR-7590 at dose level E. Subject will receive placebo at dose level E.
干预措施: SHR-7590 (Drug)
Dose Level：A
Subject will receive SHR-7590 at dose level A. Subject will receive placebo at dose level A.
干预措施: SHR-7590 (Drug)
Dose Level：A
Subject will receive SHR-7590 at dose level A. Subject will receive placebo at dose level A.
干预措施: Placebo (Drug)
Dose Level：B
Subject will receive SHR-7590 at dose level B. Subject will receive placebo at dose level B.
干预措施: SHR-7590 (Drug)
Dose Level：B
Subject will receive SHR-7590 at dose level B. Subject will receive placebo at dose level B.
干预措施: Placebo (Drug)
Dose Level：E
Subject will receive SHR-7590 at dose level E. Subject will receive placebo at dose level E.
干预措施: Placebo (Drug)
结局指标
主要结局
Serious adverse events
时间窗: From ICF signing date to Day 281
Adverse events
时间窗: From ICF signing date to Day 281
次要结局
- Maximum observed concentration of SHR-7590 (Cmax)(From 0 hour date to Day 281)
- Time to maximum observed concentration (Tmax) of SHR-7590(0 hour to Day 281)
- Half-life (T1/2) of SHR-7590(0 hour to Day 281)
- Area under the drug-time curve from 0 to the last quantifiable time point (AUC0-last) of SHR-7590(0 hour to Day 281)
- Area under the drug-time curve from time 0 to infinity of SHR-7590（AUC0-inf）(0 hour to Day 281)
- Clearance (CL) of SHR-7590(0 hour to Day 281)
- Apparent clearance（CL/F）of SHR-7590(0 hour to Day 281)
- Volume of distribution （Vd）or apparent volume of distribution （Vd/F）of SHR-7590(0 hour to Day 281)