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

NCT06980454 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Henlius Biotech

Phase

Phase 1

Started

2025-06-04

Last updated

2025-07-08

Condition(s) studied

CancermCRC

Investigational drug(s) / intervention(s)

HLX05EU-Erbitux®US-Erbitux®CN-Erbitux®

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.

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.

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.

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.

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.

Eligibility

Sex

MALE

Min age

18 Years

Max age

50 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Subjects who meet all the following criteria are allowed to be enrolled: 1. Males aged 18-50 years (inclusive); 2. Body mass index (BMI) = body weight (kg)/height2 (m2); BMI between 18.5 and 28.0 (inclusive), and body weight of male subjects ≥ 50 kg; 3. Subjects without abnormalities or those with abnormalities with no clinical significance in terms of vital signs measurement, physical examination, clinical laboratory tests (hematology, urinalysis, serum chemistry, infectious disease indicators, coagulation function, cardiac markers, alcohol screening, drug screening, etc.), 12-lead ECG examination, chest X-ray, and abdominal B ultrasound; 4. Subjects who voluntarily take effective contraceptive measures and have no sperm donation plan during the screening period and within 3 months after drug administration, and voluntarily take non-drug contraceptive measures during the trial; Exclusion Criteria: * 1\. With allergic constitution, or history of food or drug allergy; known history of allergy to any ingredient of the study drug or excipients or monoclonal antibody agents; history of infusion reactions; 2. Subjects with a history of seborrheic dermatitis or other types of dermatitis, rashes, etc., in the past or currently; 3. Subjects with a history of cardiovascular, respiratory, endocrine, hepatic, renal, gastrointestinal, nervous system, or hematological, immunological, psychiatric, metabolic obvious abnormalities, skin diseases, or other significant diseases, and are judged by the investigator as unsuitable for participating in the trial; 4. Those with hereditary bleeding tendency or coagulation disorder, or a history of thrombosis or bleeding disorders; 5. With known or suspected history of keratitis, ulcerative keratitis, or severe dry eye disease;

Primary outcome measure(s)

Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf) — up to 29 days

Trial sites (2)

Facility	City	Region	Status
Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu	Xuzhou	Jiangsu
Affiliated Hospital of Xuzhou Medical University	Jiangsu	Xuzhou

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06980454 on ClinicalTrials.gov ↗ ← All trials in China