Healthy men to test cancer Drug's new recipe
NCT ID NCT07619001
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study checks whether AK104, an experimental cancer drug, behaves the same in the body when made at a new manufacturing site versus the original site. It involves 158 healthy Chinese men who will get a single low dose of the drug. The goal is to compare drug levels in the blood, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AK104 (anti-PD-1/CTLA-4 bispecific antibody)
- What this could lead to
- If successful, this could confirm that the drug made at the new site is equivalent to the original, supporting broader manufacturing flexibility.
- What could go wrong
- This is an early-phase study in healthy volunteers, not patients. It only checks drug levels in the blood, not whether the drug works for any disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 158 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Able to provide signed informed consent prior to the trial and fully understand the trial content, procedures, and potential adverse reactions. 2. Able to complete the study as required by the trial protocol. 3. Males aged 18 to 45 years. 4. Body Mass Index (BMI) is 19.0 \~ 26.0 kg/m² and body weight is 55.0 \~ 75.0 kg. 5. 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: 1. 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. 2. 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). 3. Have a history of autoimmune disease (including personal or family history of hereditary immunodeficiency). 4. Have a history of tuberculosis or clinical manifestations suggestive of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.). 5. 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. 6. 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.). 7. Undergone major surgery or sustained severe trauma within 3 months prior to randomization, or plan to undergo surgery during the study period. 8. 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. 9. Have a known allergy to any component of the investigational drug, or a history of allergy to drugs, foods, or other substances. 10. Have difficulty with venous blood collection (e.g., unable to tolerate venipuncture, history of needle or blood phobia, poor venous access, etc.). 11. 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. 12. Urine drug screen test positive (for morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinolic acid). 13. Alcohol breath test result \> 0 mg/100 mL. 14. 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. 15. Have abnormalities in other examinations (physical examination, vital signs, chest X-ray, laboratory tests, etc.) that are considered clinically significant by the investigator. 16. Previously received any agent targeting PD-1/PD-L1 or CTLA-4. 17. Received any other investigational drug or participated in another interventional clinical trial within 3 months prior to screening. 18. 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. 19. 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. 20. 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. 21. 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. 22. 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. 23. 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. 24. Have special dietary requirements (e.g., vegetarian), are unable to comply with a standardized diet, or have lactose intolerance. 25. 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, China
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