Clinical Trial

Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics

Active, Not Recruiting Phase 1
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Record status
This record was last updated July 8, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-11.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-07-07
Trial Details
NCT Number NCT06980454
Lead Sponsor Shanghai Henlius Biotech
Conditions Cancer, mCRC
Enrollment 322 participants
Start Date 2025-06-04
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-08