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NOT YET RECRUITING
NCT07776132
PHASE1

Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11

Sponsor: Shanghai Henlius Biotech

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, parallel-controlled study to compare the PK profile of HLX29 and HLX11 and evaluate their safety, tolerability, and immunogenicity after a single intravenous dose in healthy male adult participants.

Official title: A RANDOMIZED, DOUBLE-BLIND, INTRAVENOUS SINGLE-DOSE, PARALLEL-CONTROLLED PHASE I CLINICAL STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY, AND IMMUNOGENICITY OF PERTUZUMAB INJECTION BEFORE AND AFTER PROCESS CHANGE IN HEALTHY CHINESE MALE PARTICIPANTS

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09-05

Completion Date

2027-02-01

Last Updated

2026-08-20

Healthy Volunteers

Yes

Interventions

DRUG

HLX29

Pertuzumab injection after process change

DRUG

HLX11

Pertuzumab injection before process change

Locations (1)

Anhui Medical University Second Affiliated Hospital

Hefei, Anhui, China