Clinical Trial

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

Active, Not Recruiting Phase 1
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Record status
This record was last updated March 9, 2026 (before its estimated April 10, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-06.
Status change: Recruiting → Active, Not Recruiting 2026-03-05
Trial Details
NCT Number NCT07340476
Lead Sponsor Akeso
Conditions Healthy Male Subjects
Enrollment 108 participants
Start Date 2025-12-11
Primary Completion 2026-04-10 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-09