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ACTIVE NOT RECRUITING
NCT06309043
PHASE1

A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects

Sponsor: Shanghai Henlius Biotech

View on ClinicalTrials.gov

Summary

This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects. This study is divided into two parts.

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

268

Start Date

2024-04-22

Completion Date

2026-12-31

Last Updated

2024-06-17

Healthy Volunteers

Yes

Interventions

DRUG

recombinant anti-EGFR human/murine chimeric monoclonal antibody injection

a single dose,250 mg/m2

Locations (1)

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China