drugset / Trial / NCT06980454
Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics
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.
Timeline
- Start
- 2025-06-04
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Subject | HLX05 | Monoclonal antibody | 250 mg/m2 | Intravenous |