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

NCT06980454 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2025-07-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

HLX05

A single dose of 250 mg/m2 HLX05 will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion.

DRUG

EU-Erbitux®

A single dose of 250 mg/m2 EU-Erbitux® injection will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion.

DRUG

US-Erbitux®

A single dose of 250 mg/m2 US-Erbitux® injection will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion.

DRUG

CN-Erbitux®

A single dose of 250 mg/m2 US-Erbitux® injection will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-04
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06980454 on ClinicalTrials.gov