Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This is a Single Center, Randomized, Double-blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects.
The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1209 in healthy subjects. Secondary objectives are to determine the pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1209 in healthy subjects including assessment of immunogenicity.
详细描述
32 adult healthy subjects with 4 dose groups will be enrolled in the study, including two subjects in the lowest dose group, all of whom received the SHR-1209 without placebo control. The other three groups have 10 subjects in each group, 8 administered SHR-1209 and 2 administered placebo. The primary endpoint is the Safety and Tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 and ≤45 years old;
- •The body mass index (BMI) should be 19 or greater and < 28kg/m2, the male weigh ≥50.0kg and <90.0kg, and the female weigh ≥45.0kg and <90.0kg;
- •Serum LDL-C concentration≥2.0mmol/L and < 4.1mmol/L;
- •Fasting triglycerides < 2.3 mmol/L;
- •The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication.
- •Signed informed consent.
排除标准
- •Subjects determined by the researchers have diseases that affect drug absorption, distribution, metabolism and excretion or low compliance;
- •A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs;
- •Serum creatinine exceeded the upper limit of normal value (ULN) during screening;
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT), more than 2 x ULN, or total bilirubin more than 1.5 x ULN during screening;
- •Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
- •Subjects with previous malignant tumor diseases;
- •3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs (test drug half-life more than 3 months) before screening. etc
研究组 & 干预措施
Cohort 2
A single subcutaneous injection of SHR-1209 dose 2 versus placebo
干预措施: SHR-1209 (Drug)
Cohort 1
A single subcutaneous injection of SHR-1209 dose 1 versus placebo
干预措施: SHR-1209 (Drug)
Cohort 1
A single subcutaneous injection of SHR-1209 dose 1 versus placebo
干预措施: Placebo (Drug)
Cohort 2
A single subcutaneous injection of SHR-1209 dose 2 versus placebo
干预措施: Placebo (Drug)
Cohort 3
A single subcutaneous injection of SHR-1209 dose 3 versus placebo
干预措施: SHR-1209 (Drug)
Cohort 3
A single subcutaneous injection of SHR-1209 dose 3 versus placebo
干预措施: Placebo (Drug)
Cohort 4
A single subcutaneous injection of SHR-1209 dose 4 versus placebo
干预措施: SHR-1209 (Drug)
Cohort 4
A single subcutaneous injection of SHR-1209 dose 4 versus placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Pre-dose to 150 days after dose administration
次要结局
- Assessment of PK parameter-time to maximum concentration (Tmax)(Pre-dose to 150 days after dose administration)
- Assessment of PK parameter-maximum concentration (Cmax)(Pre-dose to 150 days after dose administration)
- Assessment of PK parameter-area under curve (AUC)(Pre-dose to 150 days after dose administration)
- Assessment of PD parameter-change in Low-Density Lipoprotein Cholesterol (LDL-C) from baseline(Pre-dose to 150 days after dose administration)
- Assessment of PD parameter-change in Total Cholesterol (T-C) from baseline(Pre-dose to 150 days after dose administration)