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drugset / Trial / NCT06309043

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

NCT06309043 ↗

Phase 1 Active not recruiting 268 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-04-22
Primary completion
2026-06-01
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject HLX05 Monoclonal antibody 250 mg/m2 Intravenous

Indications

No indication recorded.