Clinical trial NCT05559554: A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Subjects
Official title: A Phase I Study to Evaluate the Similarity of Pharmacokinetic (PK) in AK104 (a PD-1/CTLA-4 Bispecific Antibody) With Different Manufacturing Process in Healthy Chinese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Keywords: AK104
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2022-09-29
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pilot study: Adverse Events (AEs)
timeFrame: Up to day 30
measure: Pivotal study: Area under the plasma concentration-time curve (AUC0-infinity)
timeFrame: From pre-dose to day 29
Secondary outcomes:
measure: Area under the plasma concentration-time curve (AUC0-t)
timeFrame: From pre-dose to day 29
measure: Maximum plasma concentration (Cmax)
timeFrame: From pre-dose to day 29
measure: Volume of distribution (Vd)
timeFrame: From pre-dose to day 29
measure: Clearance (CL)
timeFrame: From pre-dose to day 29
measure: Ratio of AUC0-t/AUC0-infinity
timeFrame: From pre-dose to day 29
measure: Time to maximum concentration (Tmax)
timeFrame: From pre-dose to day 29
measure: Half-life (t1/2)
timeFrame: From pre-dose to day 29
measure: Anti-drug Antibody (ADA)
timeFrame: From pre-dose to day 29
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Hospital of Changsha
state: Hunan
Study officials:
affiliation: The Third Hospital of Changsha
name: Xin Li, MD
role: PRINCIPAL_INVESTIGATOR
References: