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NOT YET RECRUITING
NCT07619001
PHASE1

A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Participations

Sponsor: Akeso

View on ClinicalTrials.gov

Summary

This study is to evaluate the pharmacokinetic (PK) similarity of AK104 (an anti-PD-1/CTLA-4 bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male participants.

Official title: A Phase I Study to Evaluate the PK Similarity of AK104 (Anti-PD-1/CTLA-4 Bispecific Antibody) From the Proposed New Manufacturing Site and the Approved Original Site in Chinese Healthy Male Participants.

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

158

Start Date

2026-06-01

Completion Date

2026-12-30

Last Updated

2026-06-01

Healthy Volunteers

Yes

Interventions

DRUG

AK104 (New Site)

AK104 (New Site) 0.2mg/kg

DRUG

AK104 (Original Site)

AK104 (Original Site) 0.2mg/kg

Locations (1)

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, China