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ACTIVE NOT RECRUITING
NCT07340476
PHASE1

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

Sponsor: Akeso

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2025-12-11

Completion Date

2026-07-30

Last Updated

2026-03-09

Healthy Volunteers

Yes

Interventions

DRUG

AK112 (New Site)

AK112 (New Site) 3mg/kg

DRUG

AK112 (Original Site)

AK112 (Original Site)3mg/kg

Locations (1)

Zhejiang Xiaoshan Hospital

Zhejiang, Xiaoshan, China