NCT05559554已完成1 期
A Phase I Study to Evaluate the Similarity of Pharmacokinetic (PK) in AK104 (a PD-1/CTLA-4 Bispecific Antibody) With Different Manufacturing Process in Healthy Chinese Male Subjects
Akeso1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月25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
- 100
- 试验地点
- 1
- 主要终点
- Pilot study: Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic similarity of AK104 with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of AK104 with different manufacturing process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 18 to 45;
- •Body Mass Index (BMI) is 19.0~28.0 kg/m2, and body weight is 50.0~80.0kg ;
- •Signing informed consent form before the trial and having a full understanding of the trial content, process and possible adverse reactions;
- •Able to complete the study according to the requirements of the study protocol.
排除标准
- •Those with a history of digestive tract, respiratory, cardiovascular, endocrine, urinary, neurological, hematological, metabolic and other systemic diseases;
- •Those with a history of autoimmune diseases;
- •Those with a history of malignant tumor, unless it is a skin squamous cell carcinoma, basal cell carcinoma or cervical cancer in situ that has been successfully resected and has no evidence of metastasis;
- •Regular drinkers within 6 months prior to screening;
- •Those who are suspected or confirmed to be allergic or have had severe drug or food allergy reactions in the past, have a clear history of allergies and/or are allergic to the study drug or its components after inquiries;
- •Those who have used anti-PD-1/PD-L1 or/and anti-CTLA-4 drugs in the past;
- •Those who have been vaccinated with live or attenuated-live vaccines within 3 months before screening, or who are expected to receive vaccines during the study period;
- •Those who lost blood, donated blood or received any blood product transfusion of ≥400 ml within 3 months before screening;
- •Those who received major surgery or hospitalization due to illness within 3 months before screening;
- •Abnormal laboratory tests with clinical significance at screening;
- •Positive drug screening result;
- •Have a childbirth plan within 6 months from the screening period to the trial drug administration, or who are unwilling to take the contraceptive measures specified in the protocol during the trial period.
研究组 & 干预措施
AK104 (after the change)
Experimental
Drug: AK104 (after the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes.
干预措施: AK104 (after the change) (Drug)
AK104 (before the change)
Active Comparator
Drug: AK104 (before the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes.
干预措施: AK104 (before the change) (Drug)
结局指标
主要结局
Pilot study: Adverse Events (AEs)
时间窗: Up to day 30
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Pivotal study: Area under the plasma concentration-time curve (AUC0-infinity)
时间窗: From pre-dose to day 29
次要结局
- Area under the plasma concentration-time curve (AUC0-t)(From pre-dose to day 29)
- Volume of distribution (Vd)(From pre-dose to day 29)
- Time to maximum concentration (Tmax)(From pre-dose to day 29)
- Ratio of AUC0-t/AUC0-infinity(From pre-dose to day 29)
- Anti-drug Antibody (ADA)(From pre-dose to day 29)
- Half-life (t1/2)(From pre-dose to day 29)
- Maximum plasma concentration (Cmax)(From pre-dose to day 29)
- Clearance (CL)(From pre-dose to day 29)
研究者
研究点 (1)
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