NCT04842201已完成1 期
A Phase 1, Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CM326 in Adult Healthy Volunteers
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年4月13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
- 44
- 试验地点
- 1
- 主要终点
- Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
研究概览
简要总结
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male participant,18 to 65 years of age, inclusive.
- •Body Mass Index (BMI) 18 to 26 kg/m2, inclusive.
- •History, physical examination, laboratory tests and test related items of inspection were normal or abnormal without clinically insignificant.
- •Males must abstain from sex or use highly effective methods of birth control.
- •Having given written informed consent prior to undertaking any study-related procedure.
排除标准
- •Positive for HIV, or Hepatitis B, or C.
- •Positive result on urine drug screen.
- •Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
- •With any condition that inappropriate for entry into this study.
研究组 & 干预措施
CM326
Experimental
subcutaneous injection
干预措施: CM326 (Drug)
Placebo
Placebo Comparator
subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
时间窗: Day 1 through Day 85
次要结局
- Pharmacodynamics of CM326(Day 1 through Day 85)
- Pharmacokinetics (PK) of CM326(Day 1 through Day 85)
- Immunogenicity(Day 1 through Day 85)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Single Ascending Dose Study of TD-1439 in Healthy SubjectsHealthy SubjectsNCT02903095Theravance Biopharma66
已完成
1 期
Single Ascending Dose Study of TD-0714 in Healthy SubjectsHealthyNCT02639078Theravance Biopharma56
已完成
1 期
Multiple Ascending Dose Study of TD-1439 in Healthy Adult and Elderly SubjectsHealthy Adults, Elderly SubjectsNCT02954263Theravance Biopharma40
已完成
1 期
Multiple Ascending Dose Study of TD-0714 in Healthy and Elderly SubjectsHealthy Adults, Elderly SubjectsNCT02709928Theravance Biopharma50
已完成
1 期
Single Ascending Dose Study of WAL0921 in Healthy SubjectsHealthyNCT05891366Walden Biosciences40