NCT07619001尚未招募1 期
A Phase I Study to Evaluate the PK Similarity of AK104 (Anti-PD-1/CTLA-4 Bispecific Antibody) From the Proposed New Manufacturing Site and the Approved Original Site in Chinese Healthy Male Participants.
Akeso1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2026年6月1日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 158
- 试验地点
- 1
研究概览
简要总结
This study is to evaluate the pharmacokinetic (PK) similarity of AK104 (an anti-PD-1/CTLA-4 bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male participants.
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
- •Able to provide signed informed consent prior to the trial and fully understand the trial content, procedures, and potential adverse reactions.
- •Able to complete the study as required by the trial protocol.
- •Males aged 18 to 45 years.
- •Body Mass Index (BMI) is 19.0 ~ 26.0 kg/m² and body weight is 55.0 ~ 75.0 kg.
- •Non-sterilized male participants must agree to remain completely abstinent or use a barrier contraceptive method (male condom) during the study period and for 6 months after the completion of the investigational drug infusion, and must refrain from sperm donation. Their female partners must agree to use at least one highly effective contraceptive method (e.g., sterilization surgery, contraceptive pills, injectable contraceptive medroxyprogesterone, or subdermal implant) during the study period and for 6 months after the completion of the investigational drug infusion.
排除标准
- •Have a history of diseases of the digestive, respiratory, cardiovascular, endocrine, urinary, nervous, or hematologic systems, or metabolic disorders, which, in the investigator's opinion, is still clinically significant at the time of screening.
- •Have a history of malignancy (excluding successfully resected cutaneous squamous cell carcinoma, basal cell carcinoma, or localized cervical carcinoma in situ with no evidence of metastasis).
- •Have a history of autoimmune disease (including personal or family history of hereditary immunodeficiency).
- •Have a history of tuberculosis or clinical manifestations suggestive of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.).
- •Have a history of recurrent or chronic infection, or chronic or recurrent infections including but not limited to: chronic renal infection, chronic chest infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infection, open, draining, or infected skin wounds.
- •Have a history of acute infection within 2 weeks prior to randomization, or opportunistic infection within 6 months prior to randomization (e.g., herpes zoster, active cytomegalovirus, Pneumocystis jirovecii, Histoplasma, Aspergillus, Mycobacterium, etc.).
- •Undergone major surgery or sustained severe trauma within 3 months prior to randomization, or plan to undergo surgery during the study period.
- •Donated blood or experienced significant blood loss (≥400 mL), received a blood transfusion or used blood products within 3 months prior to randomization, or plan to donate blood or blood components during the study period or within 3 months after the end of the study.
- •Have a known allergy to any component of the investigational drug, or a history of allergy to drugs, foods, or other substances.
- •Have difficulty with venous blood collection (e.g., unable to tolerate venipuncture, history of needle or blood phobia, poor venous access, etc.).
- •Have electrocardiogram abnormalities (e.g., QTcF > 450 ms, shortened or prolonged PR interval, second- or third-degree atrioventricular block, Wolff-Parkinson-White syndrome, etc.) that are considered clinically significant by the investigator.
- •Urine drug screen test positive (for morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinolic acid).
- •Alcohol breath test result > 0 mg/100 mL.
- •Have a history of hepatitis B, hepatitis C, HIV, or syphilis, or have positive diagnostic test results for hepatitis B, hepatitis C, HIV, or syphilis.
- •Have abnormalities in other examinations (physical examination, vital signs, chest X-ray, laboratory tests, etc.) that are considered clinically significant by the investigator.
- •Previously received any agent targeting PD-1/PD-L1 or CTLA-
- •Received any other investigational drug or participated in another interventional clinical trial within 3 months prior to screening.
- •Used any medication (including traditional Chinese herbs, health supplements, etc.) within 14 days prior to randomization, or within a period shorter than 5 half-lives of the last medication before the investigational drug administration day, whichever is longer.
- •Received a live or live-attenuated vaccine within 3 months prior to randomization, or an inactivated vaccine within 14 days prior to randomization, or plan to receive vaccination during the study period.
- •Have a history of drug abuse or use of soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to randomization.
- •Heavy smokers or have smoked ≥5 cigarettes per day on average within 3 months prior to randomization, or are unwilling to stop using any tobacco products during hospitalization.
- •Alcoholics or have a history of regular alcohol consumption within 6 months prior to randomization, i.e., consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer, 45 mL of spirit with 40% alcohol content, or 150 mL of wine); or are unwilling to stop alcohol consumption or any alcohol-containing products during the study period.
- •Consume excessive amounts of tea, coffee, and/or caffeinated beverages on average per day (>8 cups, 1 cup = 250 mL), or do not agree to refrain from consuming tea, coffee, and/or caffeinated foods, grapefruit (pomelo) and/or grapefruit juice, and/or products containing poppy during the study period.
- •Have special dietary requirements (e.g., vegetarian), are unable to comply with a standardized diet, or have lactose intolerance.
- •Unable to complete this study or follow the study procedures for any other reason, or are considered by the investigator to have any other condition that makes them unsuitable for participation in this study.
研究组 & 干预措施
AK104 (New site)
Experimental
AK104 (New Site) will be administrated intravenously in 60±10 minutes.
干预措施: AK104 (New Site) (Drug)
AK104 (Original site)
Active Comparator
AK104 (Original site) will be administrated intravenously in 60±10 minutes.
干预措施: AK104 (Original Site) (Drug)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study to Evaluate the PK Similarity of AK112 in Healthy Chinese Male SubjectsNCT07340476Akeso108
尚未招募
1 期
新产地（拟新增）与原产地（已获批）的抗 PD-1/CTLA-4 双特异性抗体 AK104 在中国健康男性人群中的 PK 相似性 I 期临床研究1. 本品单药用于既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者的治疗。 2.本品联合紫杉醇和铂类化疗药物联合或不联合贝伐珠单抗用于持续、复发或转移性宫颈癌的一线治疗。 胃或胃食管结合部腺癌 本品联合含氟尿嘧啶类和铂类药物化疗用于局部晚期不可切除或转移性胃或胃食管结合部腺癌患者的一线治疗。CTR20262062康方药业有限公司 / 中山康方生物医药有限公司
Unknown
2 期
一项探索 AK104（抗 PD-1 和 CTLA-4 双特异性抗体）联合盐酸安罗替尼治疗晚期非小细胞肺癌的安全性和有效性的 II 期临床研究ChiCTR2000035993慈善机构30
招募中
1 期
A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy ParticipantsOverweight , ObesityNCT07443059Beijing QL Biopharmaceutical Co.,Ltd40
Unknown
2 期
抗 PD-1 和 CTLA-4 双特异性抗体 AK104 单药或联合仑伐替尼治疗晚期肝细胞癌的 II 期临床研究ChiCTR2100046943康方药业有限公司