A Randomized, Double-Blind, Dose-Escalating, Placebo-controlled Phase I Clinical Trial on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This is a clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and immunogenicity of SHR-1139 injection in healthy subjects who receive a single subcutaneous injection or intravenous infusion of SHR-1139 injection, and in patients with moderate - to - severe plaque psoriasis who receive multiple subcutaneous injections of SHR-1139 injection.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who fully understand the trial procedures, voluntarily agree to participate, and sign a written informed consent form.
- •Age between 18 and 55 years old (inclusive).
- •Vital signs, physical examinations, laboratory tests, and other assessments are normal or show abnormalities without clinical significance.
排除标准
- •Subjects with any clinical disease in the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric systems, or metabolic abnormalities; or any other disease that may interfere with trial results.
- •History of malignant tumor.
- •Opportunistic infection within 6 months prior to screening.
- •Acute infection with systemic symptoms requiring systemic intravenous or oral anti-infective treatment within 4 weeks before baseline.
- •Participation in any drug or medical device clinical trial within 3 months prior to screening.
研究组 & 干预措施
SHR-1139 Injections Group
干预措施: SHR-1139 Injections (Drug)
SHR-1139 Injections Placebo Group
干预措施: SHR-1139 Injections Placebo (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: About 295 days for healthy subjects.
Serious adverse events (SAEs)
时间窗: About 365 days for moderate-to-severe plaque psoriasis subjects.
Adverse events (AEs)
时间窗: About 365 days for moderate-to-severe plaque psoriasis subjects
Serious adverse events (SAEs)
时间窗: About 295 days for healthy subjects.
次要结局
- Serum concentration of SHR-1139(About 365 days for moderate-to-severe plaque psoriasis subjects.)
- Serum concentration of SHR-1139(About 253 days for healthy subjects.)