A Study to Evaluate the PK Similarity of AK112 in Healthy Chinese Male Subjects

NCT07340476 | Active Not Recruiting Phase 1

• 1 other identifier: AK112-105
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic (PK) similarity of AK112 (an anti-PD-1/VEGF bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male subjects. Secondary objectives are to assess the safety, tolerability, and immunogenicity of AK112 from the proposed new manufacturing site and the approved original site.

Conditions

Healthy Male Subjects

Keywords

AK112

Outcome Measures

Primary Outcomes (1)

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

  From pre-dose to day 43

Secondary Outcomes (9)

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

  From pre-dose to day 43

• Maximum plasma concentration (Cmax)

  From pre-dose to day 43

• Volume of distribution (Vd)

  From pre-dose to day 43

• Clearance (CL)

  From pre-dose to day 43

• Ratio of AUC0-t/AUC0-infinity

  From pre-dose to day 43

Study Arms (2)

AK112 (New Site)

EXPERIMENTAL

AK112 (New Site) 3mg/kg, will be administrated intravenously in 60±10 minutes.

Drug: AK112 (New Site)

AK112 (Original Site)

ACTIVE COMPARATOR

AK112 (Original Site) 3mg/kg, will be administrated intravenously in 60±10 minutes.

Drug: AK112 (Original Site)

Interventions

AK112 (New Site) DRUG

AK112 (New Site) 3mg/kg

AK112 (New Site)

AK112 (Original Site) DRUG

AK112 (Original Site)3mg/kg

AK112 (Original Site)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Eligibility is based on biological sex and reproductive risk criteria; gender identity is not a basis for exclusion.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Males aged 18 to 45;
• Body Mass Index (BMI) is 19.0\~26.0 kg/m2, and body weight is 55.0\~75.0kg ;

You may not qualify if:

• Those with a history of hypertension or blood pressure abnormalities at screening considered clinically significant by the investigator.
• Those with a history of proteinuria or the presence of clinically significant proteinuria at screening as judged by the investigator.
• Those with a history of severe bleeding tendency or coagulation dysfunction, or a history of thrombosis or hemorrhagic events; those with a history of esophageal-gastric varices, severe ulcers, gastrointestinal obstruction, or intra-abdominal abscess; those with a history of digestive tract perforation, hemorrhage, or fistula; those with a history of transient ischemic attack (TIA), cerebrovascular accident (stroke), hypertensive crisis, or hypertensive encephalopathy; those with a current unhealed wound or fracture.
• Those with a history of autoimmune diseases (including personal or family history of hereditary immunodeficiency).
• Those with a history of malignant tumor.
• Those with a history of tuberculosis or clinical manifestations suspected to be tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.).
• Those with a history of recurrent or chronic infections, including a history of chronic or recurrent infections such as: chronic kidney infection, chronic thoracic cavity infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infections, open, draining, or infected skin wounds.
• Those with a history of acute infection within 4 weeks prior to randomization; or those with a history of opportunistic infections (e.g., herpes zoster, active cytomegalovirus, Pneumocystis jirovecii, histoplasmosis, aspergillosis, mycobacterial infections, etc.) within 6 months prior to randomization.
• Those who underwent major surgery within 3 months prior to randomization or experienced serious trauma, or those who plan to undergo surgical procedures during the trial period.
• Those who donated blood or experienced significant blood loss (≥400 mL) within 3 months prior to randomization, received blood transfusion or blood products, or plan to donate blood or blood components during the trial period or within 3 months after completion of the trial.
• Those unable to tolerate venipuncture or with a history of fainting during blood draws or injections (vasovagal reaction).
• Those with a known allergy to any component of the investigational product, or those with a history of allergy to two or more drugs, foods, or other substances.
• Those with a history of other diseases affecting the digestive, respiratory, cardiovascular, endocrine, urinary, neurological, hematologic, or metabolic systems that the investigator deems to have ongoing clinical significance.
• Those with a positive result in the urine drug screen test (for morphine, methamphetamine, ketamine, methylenedioxymethamphetamine \[MDMA\], tetrahydrocannabinol \[THC\]).
• Those with a positive alcohol breath test.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Zhejiang Xiaoshan Hospital

Zhejiang, Xiaoshan, China

Location

Study Officials

• Jinliang Chen, MD

  Zhejiang Hospital

  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: January 6, 2026
• First Posted: January 14, 2026
• Study Start: December 11, 2025
• Primary Completion: April 10, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CN (1)