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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05559554
Other study ID # AK104-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 25, 2022
Est. completion date April 6, 2023

Study information

Verified date May 2024
Source Akeso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 6, 2023
Est. primary completion date March 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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: 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AK104 (before the change)
Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.
AK104 (after the change)
Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.

Locations

Country Name City State
China The Third Hospital of Changsha Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to day 30
Primary Pivotal study: Area under the plasma concentration-time curve (AUC0-infinity) From pre-dose to day 29
Secondary Area under the plasma concentration-time curve (AUC0-t) From pre-dose to day 29
Secondary Maximum plasma concentration (Cmax) From pre-dose to day 29
Secondary Volume of distribution (Vd) From pre-dose to day 29
Secondary Clearance (CL) From pre-dose to day 29
Secondary Ratio of AUC0-t/AUC0-infinity From pre-dose to day 29
Secondary Time to maximum concentration (Tmax) From pre-dose to day 29
Secondary Half-life (t1/2) From pre-dose to day 29
Secondary Anti-drug Antibody (ADA) Number and percentage of subjects with detectable ADA From pre-dose to day 29
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