A Single-dose, Randomized, Double Blind, Placebo-controlled, Dose-increasing Study to Evaluate the Safety, Tolerability, PK Characteristics, PD Effect, and Immunogenicity of CM338 Injection in Healthy Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Safety : Incidence of Adverse Events (AEs).
研究概览
简要总结
This study was a single-center, randomized, double blind, placebo-controlled, single-dose, dose-increasing study to evaluate the safety, tolerability, PK characteristics, PD effect, and immunogenicity of CM338 injection administered intravenously or subcutaneously at different doses in healthy subjects.
详细描述
The study included screening period, baseline period, administration and hospitalization observation period, and safety follow-up period.
Sixty-six healthy volunteers will be enrolled and randomized into 8 groups.
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
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- •with the ability to understand this study and voluntarily sign the informed consent form.
- •18 to 65 years of age.
- •with normal or abnormal without clinically significance on medical history, vital signs, physical examination, 12-lead ECG, laboratory examination, chest X-ray, and abdominal color ultrasound, etc.
- •able to communicate with the researchers and follow the requirements specified in the protocol.
- •agree to use effective contraceptive methods from signing the ICF to 6 months after the administration.
排除标准
- •plan to conduct any major surgery during the study.
- •known allergy to monoclonal antibody drugs or other related drugs, or to the excipients of CM338 injection.
- •with any clinical history including serious diseases or circulatory system, endocrine system, nervous system, blood system, immune system, mental system and metabolic abnormalities.
研究组 & 干预措施
CM338 30mg, IV
30mg, single dose, IV
干预措施: CM338 (Drug)
CM338 60mg, IV
60mg, single dose, IV
干预措施: CM338 (Drug)
CM338 120mg, IV
120mg, single dose, IV
干预措施: CM338 (Drug)
CM338 240mg, IV
240mg, single dose, IV
干预措施: CM338 (Drug)
CM338 240mg, SC
240mg, single dose, SC
干预措施: CM338 (Drug)
CM338 480mg, IV
480mg, single dose, IV
干预措施: CM338 (Drug)
CM338 600mg, IV
600mg, single dose, IV
干预措施: CM338 (Drug)
CM338 600mg, SC
600mg, single dose, SC
干预措施: CM338 (Drug)
Placebo
Placebo, single dose, IV or SC
干预措施: Placebo (Drug)
结局指标
主要结局
Safety : Incidence of Adverse Events (AEs).
时间窗: Baseline up to Day 57
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
次要结局
- Pharmacokinetics (PK) parameter : Clearance rate (CL/F)(Baseline up to Day 57)
- Pharmacodynamics (PD) : C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum.(Baseline up to Day 57)
- Bioavailability : bioavailability of CM338 with SC(Baseline up to Day 57)
- Pharmacodynamics (PD) : the content of mannose-binding lectin serine protease 2 (MASP-2) in serum.(Baseline up to Day 57)
- Immunogenicity: Proportion of subjects with anti-drug antibody (ADA).(Baseline up to Day 57)
- Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)(Baseline up to Day 57)
- Pharmacokinetics (PK) parameter : Time to reach peak concentration (Tmax)(Baseline up to Day 57)
- Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)(Baseline up to Day 57)
- Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to t (AUC0-t)(Baseline up to Day 57)