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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

268

Participants

Timeline

Start Date

April 22, 2024

Primary Completion Date

June 1, 2026

Study Completion Date

December 31, 2026

Conditions
EGFR Overexpression
Interventions
DRUG

recombinant anti-EGFR human/murine chimeric monoclonal antibody injection

a single dose,250 mg/m2

Trial Locations (1)

Unknown

Affiliated Hospital of Xuzhou Medical University, Xuzhou

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY

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 | Biotech Hunter | Biotech Hunter