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

Healthy Male Subjects Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05559554
• Other study ID #: AK104-102
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 26, 2022
• Est. completion date: March 11, 2023

Study information

• Verified date: September 2022
• Source: Akeso
• Contact: Weifeng Song, MD
• Phone: +86(0760)89873999
• Email: clinicaltrials[@]akesobio.com
• Is FDA regulated: No
• 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: Not yet recruiting
• Enrollment: 132
• Est. completion date: March 11, 2023
• Est. primary completion date: January 9, 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.

Related Conditions & MeSH terms

• Healthy Male Subjects

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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

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