A Comparative Pharmacokinetic Study of CM326 in Healthy Subjects
2026年4月23日 更新者:CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
A Randomized, Open-Label, Parallel-Controlled Phase I Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of a Single Subcutaneous Injection of CM326 Via Different Delivery Devices in Healthy Subjects
This is a randomized, open-label, parallel-controlled study to compare the PK, safety, and immunogenicity of CM326 administered via different delivery devices in healthy subjects.
研究概览
研究类型
介入性
注册 (估计的)
192
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Clinical Trials Information Group officer
- 电话号码:+86-0311-69085587
- 邮箱:ctr-contact@cspc.cn
研究联系人备份
- 姓名:Wei Hu
- 电话号码:+86-13856086475
- 邮箱:huwei@ahmu.edu.com
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Participants [c1.1]must be informed of the study before it begins, fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;
- Healthy male participants aged 18 to 55 years;
- Body weight between 55.0 and 85.0 kg, and body mass index between 19.0 and 26.0 kg/m²;
- Physical examination, vital signs, 12-lead electrocardiogram, laboratory tests, and other examination results are normal, or abnormal but without clinical significance;
- Participants and their partners agree to use effective and reliable contraceptive methods from signing the ICF until 3 months after dosing;
- Participants are able to communicate well with the investigator, and to understand and comply with the requirements of the study.
Exclusion Criteria:
- History of chronic diseases or severe diseases involving the circulatory system, blood or hematopoietic system, respiratory system, endocrine system, urinary system, digestive system, immune system, psychiatric or nervous system, reproductive system, etc.;
- Presence or suspicion of any active viral, bacterial, fungal, or parasitic infection within 14 days before dosing;
- Participants who have undergone major surgery within 3 months before screening, or who plan to undergo major surgery during the study period;
- History of allergies to drugs, food, etc., or Participants who may be allergic to the study drug or its components in the Investigator's judgment;
- Positive result for any of the following: hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, human immunodeficiency virus antigen/antibody;
- History of drug abuse, or use of illicit drugs within 3 months before screening, or habitual use of any psychotropic drugs (including herbal medicines), or a positive urine drug screen;
- Blood loss or blood donation of more than 200 mL within 3 months before screening;
- Intolerance to subcutaneous injection, or presence of abdominal scars that affect subcutaneous administration, and any skin abnormalities and/or tattoos that may affect the safety assessment of the injection site;
- Use of any prescription drugs, over-the-counter drugs, herbal medicines or vitamin and dietary supplements within 14 days or 5 half-lives (whichever is longer) before dosing;
- Use of any marketed or investigational biological products within 6 months or 5 half-lives (whichever is longer) before dosing;
- Participants who have previously used CM326 or drugs targeting TSLP;
- Vaccination within 4 weeks before screening, or plan to receive such vaccines during the study;
- Participation in any clinical trial within 3 months before screening;
- Average daily smoking of more than 5 cigarettes within 3 months before screening, or unwilling to avoid using any tobacco products during the study;
- Regular alcohol consumption within 3 months before screening, defined as weekly alcohol consumption exceeding 14 units (1 unit = 360 mL of 5% alcohol beer or 45 mL of 40% alcohol spirits or 150 mL of 12% alcohol wine), or inability to stop alcohol intake during the study, or a positive blood alcohol test;
- Regular consumption of excessive amounts of tea, coffee, and/or caffeinated beverages within 3 months before screening;
- Participants who have special dietary requirements and are unable to comply with the standardized diet;
- History of needle phobia or hemophobia, or d difficulty with venipuncture or unable to tolerate venous puncture;
- Participants who, in the Investigator's judgment, may be unable to complete the study for other reasons or are considered unsuitable for enrollment.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:CM326 group 1
Subjects will receive a single subcutaneous injection of CM326 on Day 1.
|
subcutaneous injection
|
|
实验性的:CM326 group 2
Subjects will receive a single subcutaneous injection of CM326 on Day 1.
|
subcutaneous injection
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum concentration (Cmax)
大体时间:Pre-dose at day 1 to Day 113
|
To compare the Cmax of CM326 administered via different delivery devices
|
Pre-dose at day 1 to Day 113
|
|
Area under the concentration-time curve from zero to infinity (AUCinf)
大体时间:Pre-dose at day 1 to Day 113
|
To compare the AUCinf of CM326 administered via different delivery devices
|
Pre-dose at day 1 to Day 113
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to maximum concentration (Tmax)
大体时间:Pre-dose at day 1 to Day 113
|
To characterize the Tmax of CM326 in healthy subjects
|
Pre-dose at day 1 to Day 113
|
|
Area under the concentration-curve from zero to the last quantifiable concentration (AUClast)
大体时间:Pre-dose at day 1 to Day 113
|
To characterize the AUClast of CM326 in healthy subjects
|
Pre-dose at day 1 to Day 113
|
|
Terminal elimination half-life (t1/2)
大体时间:Pre-dose at day 1 to Day 113
|
To characterize the t1/2 of CM326 in healthy subjects
|
Pre-dose at day 1 to Day 113
|
|
Apparent clearance (CL/F)
大体时间:Pre-dose at day 1 to Day 113
|
To characterize the Vz/F of CM326 in healthy subjects
|
Pre-dose at day 1 to Day 113
|
|
Apparent volume of distribution (Vz/F)
大体时间:Pre-dose at day 1 to Day 113
|
To characterize the Vz/F of CM326 in healthy subjects
|
Pre-dose at day 1 to Day 113
|
|
Number of subjects with adverse events as Assessed by CTCAE v6.0
大体时间:Pre-dose at day 1 to Day 113
|
To assess the safety of CM326 in healthy subjects
|
Pre-dose at day 1 to Day 113
|
|
Incidence of ADA
大体时间:Pre-dose at day 1 to Day 113
|
To assess the immunogenicity of CM326 in healthy subjects
|
Pre-dose at day 1 to Day 113
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年4月20日
初级完成 (估计的)
2026年10月1日
研究完成 (估计的)
2026年12月31日
研究注册日期
首次提交
2026年4月14日
首先提交符合 QC 标准的
2026年4月23日
首次发布 (实际的)
2026年4月30日
研究记录更新
最后更新发布 (实际的)
2026年4月30日
上次提交的符合 QC 标准的更新
2026年4月23日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他研究编号
- CM326-006
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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