NCT05432544进行中（未招募）1 期
A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injection of SHR-1918 Injection in Healthy Subjects
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年6月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To assess the number of subjects with serious adverse events (SAEs)
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of SHR-1918 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-1918 injection in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age ≥18 and ≤65 on the date of signing the informed consent, males or females;
- •1.7 mmol/L≤TG≤5.6 mmol/L，2.6 mmol/L≤LDL-C<4.9 mmol/L;
- •Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.
排除标准
- •1.History of disease or treatment for:
- •Known allergic reaction to experimental drugs or severe allergic reaction to other antibody drugs;
- •Combined cardiovascular, hepatic, renal, gastrointestinal, neuropsychiatric, hematological, or metabolic diseases;
- •History of any drug use prior to screening or within 2 weeks prior to baseline
- •2.Any one of the following tests at screening :
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) exceeding 2 times ULN, or total bilirubin exceeding 1.5 times ULN
- •Creatine kinase (CK) exceeding 3 times the upper limit of normal (ULN)
- •History of drug or substance abuse;
- •Average of 5 or more cigarettes per day during the 4 weeks prior to screening;
- •History of blood donation within 3 months prior to screening, or severe blood loss (≥400 mL blood loss), or received a blood transfusion within 4 weeks;
- •Vaccination within 2 weeks prior to screening or planned during the course of the trial
- •4.The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.
研究组 & 干预措施
SAD, SHR-1918
Experimental
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 injection
干预措施: SHR-1918 (Drug)
SAD, SHR-1918 placebo
Placebo Comparator
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-1918 placebo injection
干预措施: SHR-1918 placebo (Drug)
结局指标
主要结局
To assess the number of subjects with serious adverse events (SAEs)
时间窗: up to day 190
To assess the number of subjects with adverse events (AEs)
时间窗: up to day 190
次要结局
- To assess VLDL-C.(up to day 190)
- To assess ADA(or/and Nab).(up to day 190)
- To assess ApoA1(up to day 190)
- To assess Tmax(up to day 190)
- To assess HDL-C(up to day 190)
- To assess CL/F(up to day 190)
- To assess TG(up to day 190)
- To assess ApoB(up to day 190)
- To assess AUC0-t(up to day 190)
- To assess t1/2(up to day 190)
- To assess 、V/F.(up to day 190)
- To assess LDL-C(up to day 190)
- To assess AUC0-∞(up to day 190)
- To assess Cmax(up to day 190)
- To assess TC(up to day 190)
- To assess Lp(a)(up to day 190)
研究者
研究点 (1)
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