A Study to Evaluate the PK Similarity of AK112 in Healthy Chinese Male Subjects (NCT07340476) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate the PK Similarity of AK112 in Healthy Chinese Male Subjects
China108 participantsStarted 2025-12-11
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexMALE
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Inclusion criteria
✓. 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 ;
Exclusion criteria
✕. 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.).
What they're measuring
1
Area under the plasma concentration-time curve (AUC0-infinity)
✕. 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.