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

Henlius Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Cancer; mCRC

Treatments: Drug: EU-Erbitux®; Drug: CN-Erbitux®; Drug: HLX05; Drug: US-Erbitux®

Study type: Interventional

Funder types: Industry

Identifiers

NCT06980454

HLX05-HV01

Details and patient eligibility

About

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.

Enrollment: 322 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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322 participants in 4 patient groups

HLX05

Experimental group

Treatment:

Drug: HLX05

US-sourced Erbitux®

Active Comparator group

Treatment:

Drug: US-Erbitux®

CN-sourced Erbitux®

Active Comparator group

Treatment:

Drug: CN-Erbitux®

EU-sourced Erbitux®

Active Comparator group

Treatment:

Drug: EU-Erbitux®