NCT05171348已完成1 期
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Multiple Ascending Doses of CM326 Injection by Subcutaneous Administration in Healthy Subjects
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月7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
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, PK profile, and immunogenicity of multiple SC administraion of CM326 at different doses in healthy subjects.
40 healthy male subjects will be enrolled in the study. The drug will be administered by dose-escalating principle at 4 dose levels: 55 mg Q2W, 110 mg Q2W, 220 mg Q2W, 220 mg Q4W.
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
- •Male healthy volunteers, aged between 18 and 65 years of age inclusive, with a body mass index (BMI) within 18-26 kg/m2 (inclusive);
- •Medical history, vital signs, physical examination, 12-lead Electrocardiogram, chest X-ray and abdominal color ultrasound are normal or abnormal with no clinical significance;
- •All variables of clinical laboratory tests are normal or abnormal with no clinical significance;
- •Subjects and partners agree to take effective contraception throughout the study (from screening to 3 months after the end of treatment);
- •Capable of understanding the nature of the study and voluntarily signing the Informed Consent Form.
排除标准
- •Known allergy to monoclonal antibody drugs or other related drugs, or allergy to excipients of CM326 injection;
- •History of any clinically serious disease or history of circulatory, endocrine, neurological or hematological, immune, psychiatric, and metabolic diseases;
- •History of asthma and allergic reactions;
- •Use of any prescription drugs within 2 weeks prior to dosing, use of traditional Chinese medicine or over-the-counter drugs within 1 week prior to dosing;
- •Received any marketed or investigational biologics within 5 half-lives (if known) or 12 weeks (whichever is longer) prior to dosing, or any investigational non-biologics within 5 half-lives (if known) or 4 weeks (whichever is longer) prior to dosing.
研究组 & 干预措施
CM326 55mg Q2W
Experimental
55mg for 6 doses, SC, Q2W
干预措施: CM326 (Drug)
CM326 110mg Q2W
Experimental
110mg for 6 doses, SC, Q2W
干预措施: CM326 (Drug)
CM326 220mg Q2W
Experimental
220mg for 6 doses, SC, Q2W
干预措施: CM326 (Drug)
CM326 220mg Q4W
Experimental
220mg for 3 doses, SC, Q4W
干预措施: CM326 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: up to Week 24
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
次要结局
- Immunogenicity endpoints: Occurrence of anti-drug antibodies (ADA) to CM326.(up to Week 16)
- PK parameters: time to maximum concentration (Tmax).(up to Week 16)
- PK parameters: maximum concentration (Cmax).(up to Week 16)
- PK parameters: area under the plasma concentration-time curve over a dosing interval (AUCtau).(up to Week 16)
- PK parameters: area under the plasma concentration-time curve from 0 to t (AUC0-t).(up to Week 16)
研究者
研究点 (1)
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