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

NCT05559554 | Completed Phase 1

• 1 other identifier: AK104-102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Male Subjects

Keywords

AK104

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

Study Arms (2)

AK104 (after the change)

EXPERIMENTAL

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

Drug: AK104 (after the change)

AK104 (before the change)

ACTIVE COMPARATOR

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

Drug: AK104 (before the change)

Interventions

AK104 (before the change) DRUG

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

AK104 (before the change)

AK104 (after the change) DRUG

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

AK104 (after the change)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Those with a history of digestive tract, respiratory, cardiovascular, endocrine, urinary, neurological, hematological, metabolic and other systemic diseases;
• Those with a history of autoimmune diseases;
• 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;
• Regular drinkers within 6 months prior to screening;
• 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;
• Those who have used anti-PD-1/PD-L1 or/and anti-CTLA-4 drugs in the past;
• 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;
• Those who lost blood, donated blood or received any blood product transfusion of ≥400 ml within 3 months before screening;
• Those who received major surgery or hospitalization due to illness within 3 months before screening;
• Abnormal laboratory tests with clinical significance at screening;
• Positive drug screening result;
• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

The Third Hospital of Changsha

Changsha, Hunan, China

Location

Study Officials

• Xin Li, MD

  The Third Hospital of Changsha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: October 25, 2022
• Primary Completion: March 24, 2023
• Study Completion: April 6, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CN (1)