A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Participations (NCT07619001) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Participations
China158 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the plasma concentration-time curve (AUC0-infinity)
. 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.