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CompletedNCT05559554Updated May 16, 2024

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

A Phase 1 interventional study of AK104 (before the change) and AK104 (after the change) in Healthy Male Subjects, sponsored by Akeso. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Akeso · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

The purpose of this study is to evaluate the pharmacokinetic similarity of AK104 with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of AK104 with different manufacturing process.

02

Conditions studied

  • Healthy Male Subjects

Keywords

  • AK104
03

In context

Lead sponsor

Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Males aged 18 to 45;
  2. Body Mass Index (BMI) is 19.0\~28.0 kg/m2, and body weight is 50.0\~80.0kg ;
  3. Signing informed consent form before the trial and having a full understanding of the trial content, process and possible adverse reactions;
  4. Able to complete the study according to the requirements of the study protocol.

Exclusion criteria

Exclusion Criteria:

  1. Those with a history of digestive tract, respiratory, cardiovascular, endocrine, urinary, neurological, hematological, metabolic and other systemic diseases;
  2. Those with a history of autoimmune diseases;
  3. Those with a history of malignant tumor, unless it is a skin squamous cell carcinoma, basal cell carcinoma or cervical cancer in situ that has been successfully resected and has no evidence of metastasis;
  4. Regular drinkers within 6 months prior to screening;
  5. Those who are suspected or confirmed to be allergic or have had severe drug or food allergy reactions in the past, have a clear history of allergies and/or are allergic to the study drug or its components after inquiries;
  6. Those who have used anti-PD-1/PD-L1 or/and anti-CTLA-4 drugs in the past;
  7. Those who have been vaccinated with live or attenuated-live vaccines within 3 months before screening, or who are expected to receive vaccines during the study period;
  8. Those who lost blood, donated blood or received any blood product transfusion of ≥400 ml within 3 months before screening;
  9. Those who received major surgery or hospitalization due to illness within 3 months before screening;
  10. Abnormal laboratory tests with clinical significance at screening;
  11. Positive drug screening result;
  12. Have a childbirth plan within 6 months from the screening period to the trial drug administration, or who are unwilling to take the contraceptive measures specified in the protocol during the trial period.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    AK104 (after the change)

    Drug: AK104 (after the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes.

    Drug: AK104 (after the change)

  • Active comparator
    AK104 (before the change)

    Drug: AK104 (before the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes.

    Drug: AK104 (before the change)

Interventions

  • DrugAK104 (before the change)

    Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.

  • DrugAK104 (after the change)

    Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.

06

What researchers measure

Primary outcomes

  1. Pilot study: Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

    Time frame: Up to day 30

  2. Pivotal study: Area under the plasma concentration-time curve (AUC0-infinity)

    Time frame: From pre-dose to day 29

Secondary outcomes

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

    Time frame: From pre-dose to day 29

  2. Maximum plasma concentration (Cmax)

    Time frame: From pre-dose to day 29

  3. Volume of distribution (Vd)

    Time frame: From pre-dose to day 29

  4. Clearance (CL)

    Time frame: From pre-dose to day 29

  5. Ratio of AUC0-t/AUC0-infinity

    Time frame: From pre-dose to day 29

  6. Time to maximum concentration (Tmax)

    Time frame: From pre-dose to day 29

  7. Half-life (t1/2)

    Time frame: From pre-dose to day 29

  8. Anti-drug Antibody (ADA)

    Number and percentage of subjects with detectable ADA

    Time frame: From pre-dose to day 29

07

Study locations

1 site
  • The Third Hospital of Changsha
    Changsha, Hunan, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05559554
Lead sponsor
Akeso
Responsible party
Sponsor
First posted
Sep 29, 2022
Start date
Oct 25, 2022
Primary completion
Mar 24, 2023
Completion
Apr 6, 2023
Last update
May 16, 2024

Study contacts

Xin Li, MD
principal investigator · The Third Hospital of Changsha

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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