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Healthy Male Adults ParticipantsPhase 1NCT07619001

A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Participations

A Phase 1 study testing AK104 (New Site) and AK104 (Original Site) in people with Healthy Male Adults Participants, run by Akeso at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Male Adults Participants
What is being tested?
AK104 (New Site) and AK104 (Original Site)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteChina
Study dates
1 Jun 2026to 30 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.).
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  • 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-4.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Zhejiang Xiaoshan Hospital

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: 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.

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.

Being tested
AK104 (New Site), AK104 (Original Site)
Keywords
AK104

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK104 (New Site)Drug

    AK104 (New Site) 0.2mg/kg

  • AK104 (Original Site)Drug

    AK104 (Original Site) 0.2mg/kg

Study groups in NCT07619001
Study groupRoleWhat they receive
AK104 (New site)ExperimentalAK104 (New Site) will be administrated intravenously in 60±10 minutes.
Receives: Drug: AK104 (New Site)
AK104 (Original site)Active comparatorAK104 (Original site) will be administrated intravenously in 60±10 minutes.
Receives: Drug: AK104 (Original Site)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the plasma concentration-time curve (AUC0-infinity)

    Measured: From pre-dose to day 22

Secondary outcomes (9)

  1. Area under the plasma concentration-time curve (AUC0-t)

    Measured: From pre-dose to day 22

  2. Maximum plasma concentration (Cmax)

    Measured: From pre-dose to day 22

  3. Volume of distribution (V)

    Measured: From pre-dose to day 22

  4. Clearance (CL)

    Measured: From pre-dose to day 22

  5. Ratio of AUC0-t/AUC0-infinity

    Measured: From pre-dose to day 22

  6. Time to maximum concentration (Tmax)

    Measured: From pre-dose to day 22

  7. Half-life (t1/2)

    Measured: From pre-dose to day 22

  8. Incidence and severity of adverse events (AEs)

    Measured: Up to day 22

  9. Number and percentage of subjects with detectable ADA

    Measured: From pre-dose to day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
158 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07619001
Sponsor's protocol ID
AK104-103
Status last verified
May 2026
First submitted
26 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AK104 (New Site) and AK104 (Original Site) in people with Healthy Male Adults Participants, run by Akeso at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the plasma concentration-time curve (AUC0-infinity) (time frame: From pre-dose to day 22). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07619001.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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