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

NCT07619001 | Not Yet Recruiting Phase 1

• 1 other identifier: AK104-103
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the pharmacokinetic (PK) similarity of AK104 (an anti-PD-1/CTLA-4 bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male participants.

Conditions

Healthy Male Adults Participants

Keywords

AK104

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration-time curve (AUC0-infinity)

  From pre-dose to day 22

Secondary Outcomes (9)

• Area under the plasma concentration-time curve (AUC0-t)

  From pre-dose to day 22

• Maximum plasma concentration (Cmax)

  From pre-dose to day 22

• Volume of distribution (V)

  From pre-dose to day 22

• Clearance (CL)

  From pre-dose to day 22

• Ratio of AUC0-t/AUC0-infinity

  From pre-dose to day 22

Study Arms (2)

AK104 (New site)

EXPERIMENTAL

AK104 (New Site) will be administrated intravenously in 60±10 minutes.

Drug: AK104 (New Site)

AK104 (Original site)

ACTIVE COMPARATOR

AK104 (Original site) will be administrated intravenously in 60±10 minutes.

Drug: AK104 (Original Site)

Interventions

AK104 (New Site) DRUG

AK104 (New Site) 0.2mg/kg

AK104 (New site)

AK104 (Original Site) DRUG

AK104 (Original Site) 0.2mg/kg

AK104 (Original site)

Eligibility Criteria

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

You may qualify if:

• Able to provide signed informed consent prior to the trial and fully understand the trial content, procedures, and potential adverse reactions.
• Able to complete the study as required by the trial protocol.
• Males aged 18 to 45 years.
• Body Mass Index (BMI) is 19.0 \~ 26.0 kg/m² and body weight is 55.0 \~ 75.0 kg.
• Non-sterilized male participants must agree to remain completely abstinent or use a barrier contraceptive method (male condom) during the study period and for 6 months after the completion of the investigational drug infusion, and must refrain from sperm donation. Their female partners must agree to use at least one highly effective contraceptive method (e.g., sterilization surgery, contraceptive pills, injectable contraceptive medroxyprogesterone, or subdermal implant) during the study period and for 6 months after the completion of the investigational drug infusion.

You may not qualify if:

• Have a history of diseases of the digestive, respiratory, cardiovascular, endocrine, urinary, nervous, or hematologic systems, or metabolic disorders, which, in the investigator's opinion, is still clinically significant at the time of screening.
• Have a history of malignancy (excluding successfully resected cutaneous squamous cell carcinoma, basal cell carcinoma, or localized cervical carcinoma in situ with no evidence of metastasis).
• Have a history of autoimmune disease (including personal or family history of hereditary immunodeficiency).
• Have a history of tuberculosis or clinical manifestations suggestive of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.).
• Have a history of recurrent or chronic infection, or chronic or recurrent infections including but not limited to: chronic renal infection, chronic chest infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infection, open, draining, or infected skin wounds.
• Have a history of acute infection within 2 weeks prior to randomization, or opportunistic infection within 6 months prior to randomization (e.g., herpes zoster, active cytomegalovirus, Pneumocystis jirovecii, Histoplasma, Aspergillus, Mycobacterium, etc.).
• Undergone major surgery or sustained severe trauma within 3 months prior to randomization, or plan to undergo surgery during the study period.
• Donated blood or experienced significant blood loss (≥400 mL), received a blood transfusion or used blood products within 3 months prior to randomization, or plan to donate blood or blood components during the study period or within 3 months after the end of the study.
• Have a known allergy to any component of the investigational drug, or a history of allergy to drugs, foods, or other substances.
• Have difficulty with venous blood collection (e.g., unable to tolerate venipuncture, history of needle or blood phobia, poor venous access, etc.).
• Have electrocardiogram abnormalities (e.g., QTcF \> 450 ms, shortened or prolonged PR interval, second- or third-degree atrioventricular block, Wolff-Parkinson-White syndrome, etc.) that are considered clinically significant by the investigator.
• Urine drug screen test positive (for morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinolic acid).
• Alcohol breath test result \> 0 mg/100 mL.
• Have a history of hepatitis B, hepatitis C, HIV, or syphilis, or have positive diagnostic test results for hepatitis B, hepatitis C, HIV, or syphilis.
• Have abnormalities in other examinations (physical examination, vital signs, chest X-ray, laboratory tests, etc.) that are considered clinically significant by the investigator.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, China

Location

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: May 26, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)