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NOT YET RECRUITING
NCT07495930
PHASE1

Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®

Sponsor: Shanghai Henlius Biotech

View on ClinicalTrials.gov

Summary

The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent clinical study protocols.

Official title: A Randomized, Double-blind, Single Subcutaneous Administration, Parallel Control Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo® in Chinese Healthy Male Subjects.

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-04-30

Completion Date

2026-10-10

Last Updated

2026-04-01

Healthy Volunteers

Yes

Interventions

DRUG

HLX319

HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).

DRUG

EU-Phesgo

EU-Phesgo is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).

Locations (1)

Anhui Medical University Second Affiliated Hospital

Hefei, Anhui, China