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

Phase 1

Not yet recruiting

• Conditions: Cancer; mCRC
• Interventions: Drug: HLX05; Drug: US-Erbitux®; Drug: CN-Erbitux®; Drug: EU-Erbitux®

• Registration Number: NCT06980454
• Lead Sponsor: Shanghai Henlius Biotech

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-29
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-11
• Last Update Submitted: 2025-05-11
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-05-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 322

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HLX05	HLX05	-
US-sourced Erbitux®	US-Erbitux®	-
CN-sourced Erbitux®	CN-Erbitux®	-
EU-sourced Erbitux®	EU-Erbitux®	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cmax	up to 29 days	Maximum serum concentration
Tmax	up to 29 days	Time to reach maximum serum concentration
CL	up to 29 days	Total clearance
λz	up to 29 days	Apparent terminal elimination rate constant