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Healthy Male SubjectsPhase 1NCT07340476

A Study to Evaluate the PK Similarity of AK112 in Healthy Chinese Male Subjects

A Phase 1 study testing AK112 (New Site) and AK112 (Original Site) in people with Healthy Male Subjects, run by Akeso at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to evaluate the pharmacokinetic (PK) similarity of AK112 (an anti-PD-1/VEGF bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male subjects. 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 Subjects
What is being tested?
AK112 (New Site) and AK112 (Original Site)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteChina
Study dates
11 Dec 2025to 30 Jul 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

  • 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.
  • Males aged 18 to 45;
  • Body Mass Index (BMI) is 19.0~26.0 kg/m2, and body weight is 55.0~75.0kg ;

Who cannot join

  • Those with a history of hypertension or blood pressure abnormalities at screening considered clinically significant by the investigator.
  • Those with a history of proteinuria or the presence of clinically significant proteinuria at screening as judged by the investigator.
  • Those with a history of severe bleeding tendency or coagulation dysfunction, or a history of thrombosis or hemorrhagic events; those with a history of esophageal-gastric varices, severe ulcers, gastrointestinal obstruction, or intra-abdominal abscess; those with a history of digestive tract perforation, hemorrhage, or fistula; those with a history of transient ischemic attack (TIA), cerebrovascular accident (stroke), hypertensive crisis, or hypertensive encephalopathy; those with a current unhealed wound or fracture.
  • Those with a history of autoimmune diseases (including personal or family history of hereditary immunodeficiency).
  • Those with a history of malignant tumor.
  • Those with a history of tuberculosis or clinical manifestations suspected to be tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.).
Show all 27Show fewer
  • Those with a history of recurrent or chronic infections, including a history of chronic or recurrent infections such as: chronic kidney infection, chronic thoracic cavity infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infections, open, draining, or infected skin wounds.
  • Those with a history of acute infection within 4 weeks prior to randomization; or those with a history of opportunistic infections (e.g., herpes zoster, active cytomegalovirus, Pneumocystis jirovecii, histoplasmosis, aspergillosis, mycobacterial infections, etc.) within 6 months prior to randomization.
  • Those who underwent major surgery within 3 months prior to randomization or experienced serious trauma, or those who plan to undergo surgical procedures during the trial period.
  • Those who donated blood or experienced significant blood loss (≥400 mL) within 3 months prior to randomization, received blood transfusion or blood products, or plan to donate blood or blood components during the trial period or within 3 months after completion of the trial.
  • Those unable to tolerate venipuncture or with a history of fainting during blood draws or injections (vasovagal reaction).
  • Those with a known allergy to any component of the investigational product, or those with a history of allergy to two or more drugs, foods, or other substances.
  • Those with a history of other diseases affecting the digestive, respiratory, cardiovascular, endocrine, urinary, neurological, hematologic, or metabolic systems that the investigator deems to have ongoing clinical significance.
  • Those with a positive result in the urine drug screen test (for morphine, methamphetamine, ketamine, methylenedioxymethamphetamine [MDMA], tetrahydrocannabinol [THC]).
  • Those with a positive alcohol breath test.
  • Those who test positive for any of the following: Human Immunodeficiency Virus (HIV) antibody, Hepatitis C Virus (HCV) antibody, Syphilis test (RPR), Hepatitis B Virus (HBV) surface antigen, e-antigen (HBeAg), or core antibody (HBcAb).
  • Those with abnormal findings in other examinations (physical examination, vital signs, chest X-ray, laboratory tests, etc.) that are considered clinically significant by the investigator.
  • Those who have previously used any drug targeting PD-1, PD-L1, VEGF, or VEGFR pathways.
  • Those who received other investigational medicinal products or participated in another interventional clinical trial within 3 months prior to randomization.
  • Those vaccinated with live or attenuated vaccines within 3 months prior to randomization, or those vaccinated with inactivated vaccines within 14 days prior to randomization, or those who plan to receive vaccinations during the trial period.
  • Those who used any medication (including traditional Chinese medicine, health supplements, etc.) within 14 days prior to randomization, or those whose last dose was administered less than 5 half-lives before the randomization date, whichever is longer.
  • Those with a history of drug abuse or those who used soft drugs (e.g., marijuana) or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to receiving the investigational product.
  • Those who are smokers or smoked more than 5 cigarettes per day within 3 months prior to randomization, or those unable to abstain from all tobacco products during hospitalization.
  • Those who are heavy drinkers or frequent drinkers within 12 months prior to randomization, defined as consuming more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL spirits [40% alcohol] or 150 mL wine); or those unwilling to abstain from alcohol or any alcoholic beverages during the trial period.
  • Those with special dietary requirements that prevent compliance with the standardized diet, or those who are lactose intolerant.
  • Those whose subject or partner has plans for pregnancy during the study period through 3 months after trial completion, or those unwilling to use reliable contraceptive measures (such as abstinence, sterilization, oral contraceptives, injectable contraceptives like medroxyprogesterone acetate, subdermal implants, condoms, etc.).
  • Those who may be unable to complete this study for other reasons, or those unable to comply with the study procedures during the study period, or those deemed by the investigator to have other reasons making them unsuitable for participation in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhejiang Xiaoshan Hospital

    Zhejiang, Xiaoshan

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the PK Similarity of AK112 (Anti-PD-1/VEGF Bispecific Antibody) From the Proposed New Manufacturing Site and the Approved Original Site in Chinese Healthy Male Subjects.

The purpose of this study is to evaluate the pharmacokinetic (PK) similarity of AK112 (an anti-PD-1/VEGF bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male subjects.

Secondary objectives are to assess the safety, tolerability, and immunogenicity of AK112 from the proposed new manufacturing site and the approved original site.

Being tested
AK112 (New Site), AK112 (Original Site)
Keywords
AK112

What participants receive

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

  • AK112 (New Site)Drug

    AK112 (New Site) 3mg/kg

  • AK112 (Original Site)Drug

    AK112 (Original Site)3mg/kg

Study groups in NCT07340476
Study groupRoleWhat they receive
AK112 (New Site)ExperimentalAK112 (New Site) 3mg/kg, will be administrated intravenously in 60±10 minutes.
Receives: Drug: AK112 (New Site)
AK112 (Original Site)Active comparatorAK112 (Original Site) 3mg/kg, will be administrated intravenously in 60±10 minutes.
Receives: Drug: AK112 (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 43

Secondary outcomes (9)

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

    Measured: From pre-dose to day 43

  2. Maximum plasma concentration (Cmax)

    Measured: From pre-dose to day 43

  3. Volume of distribution (Vd)

    Measured: From pre-dose to day 43

  4. Clearance (CL)

    Measured: From pre-dose to day 43

  5. Ratio of AUC0-t/AUC0-infinity

    Measured: From pre-dose to day 43

  6. Time to maximum concentration (Tmax)

    Measured: From pre-dose to day 43

  7. Half-life (t1/2)

    Measured: From pre-dose to day 43

  8. Incidence and severity of adverse events (AEs)

    Measured: Up to day 43

  9. Number and percentage of subjects with detectable ADA

    Measured: From pre-dose to day 43

Timeline

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

  1. First posted14 Jan 2026
  2. Study start11 Dec 2025
  3. Primary completion10 Apr 2026 (estimated)
  4. Study completion30 Jul 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
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07340476
Sponsor's protocol ID
AK112-105
Status last verified
Mar 2026
First submitted
6 Jan 2026
Last updated
9 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AK112 (New Site) and AK112 (Original Site) in people with Healthy Male Subjects, 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 4 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 9 Mar 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 43). 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 NCT07340476.

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 9 Mar 2026.

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