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

NCT07619001 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • Healthy Male Adults Participants

Interventions

DRUG

AK104 (New Site)

AK104 (New Site) 0.2mg/kg

DRUG

AK104 (Original Site)

AK104 (Original Site) 0.2mg/kg

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-09-30
Completion
2026-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07619001 on ClinicalTrials.gov