MedTrace Logo

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

NCT07340476 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-03-09

No results posted yet for this study

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

DRUG

AK112 (New Site)

AK112 (New Site) 3mg/kg

DRUG

AK112 (Original Site)

AK112 (Original Site)3mg/kg

Sponsors & Collaborators

Principal Investigators

  • Jinliang Chen, MD · Zhejiang Hospital

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
2025-12-11
Primary Completion
2026-04-10
Completion
2026-07-30

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 NCT07340476 on ClinicalTrials.gov