NCT07340476

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

A Phase I Study to Evaluate the PK Similarity of AK112 (Anti-PD-1/VEGF Bispecific Antibody) From the Proposed New Manufacturing Site and the Approved Original Site in Chinese Healthy Male Subjects.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Akeso · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	AK112 (New Site)	AK112 (New Site) 3mg/kg
DRUG	AK112 (Original Site)	AK112 (Original Site)3mg/kg

Timeline

• Start date: 2025-12-11
• Primary completion: 2026-04-10
• Completion: 2026-07-30
• First posted: 2026-01-14
• Last updated: 2026-03-09

Locations

1 site across 1 country: China