Trials / Active Not Recruiting
Active Not RecruitingNCT06309043
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 268 (estimated)
- Sponsor
- Shanghai Henlius Biotech · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | recombinant anti-EGFR human/murine chimeric monoclonal antibody injection | a single dose，250 mg/m2 |
Timeline
- Start date
- 2024-04-22
- Primary completion
- 2026-06-01
- Completion
- 2026-12-31
- First posted
- 2024-03-13
- Last updated
- 2024-06-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06309043. Inclusion in this directory is not an endorsement.