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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: AK104 (after the change); Drug: AK104 (before the change)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • The Third Hospital of Changsha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.
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); Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pivotal study: Area under the plasma concentration-time curve (AUC0-infinity)		From pre-dose to day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration-time curve (AUC0-t)		From pre-dose to day 29
Maximum plasma concentration (Cmax)		From pre-dose to day 29
Volume of distribution (Vd)		From pre-dose to day 29
Clearance (CL)		From pre-dose to day 29
Ratio of AUC0-t/AUC0-infinity		From pre-dose to day 29
Time to maximum concentration (Tmax)		From pre-dose to day 29
Half-life (t1/2)		From pre-dose to day 29
Anti-drug Antibody (ADA)	Number and percentage of subjects with detectable ADA	From pre-dose to day 29

Collaborators and Investigators

• Sponsor: Akeso
• Investigators: Principal Investigator: Xin Li, MD, The Third Hospital of Changsha

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): April 6, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: AK104
• Other Study ID Numbers: AK104-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No