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

Phase 1

Active, not recruiting

• Conditions: EGFR Overexpression
• Interventions: Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection

• Registration Number: NCT06309043
• 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. This study is divided into two parts.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-13
• Study Start: 2024-04-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-17
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 268

Inclusion Criteria

• 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; 5. After fully understanding the content of the trial and possible adverse reactions, the subjects who voluntarily participate in the trial, are willing to sign the informed consent form (ICF), and are able to complete the study in accordance with the trial protocol.

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 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;
3. Those with hereditary bleeding tendency or coagulation disorder, or a history of thrombosis or bleeding disorders;
4. With known or suspected history of keratitis, ulcerative keratitis, or severe dry eye disease;
5. With a history of surgery within 3 months prior to screening, or planned surgery during the trial;
6. Intolerant to venipuncture or with a history of needle or blood phobia;
7. With a history of drug abuse within 6 months prior to screening;
8. Use of narcotics within 3 months prior to screening;
9. Subjects who have donated blood including blood components or lost blood (≥ 200 mL), received blood transfusion, or used blood products within 3 months prior to screening;
10. Subjects who have received anti-EGFR targeted drugs (including monoclonal antibodies and TKIs) or other monoclonal antibodies within 3 months prior to screening;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HLX05	recombinant anti-EGFR human/murine chimeric monoclonal antibody injection	-
US-sourced Erbitux	recombinant anti-EGFR human/murine chimeric monoclonal antibody injection	-
CN-sourced Erbitux	recombinant anti-EGFR human/murine chimeric monoclonal antibody injection	-
EU-sourced Erbitux	recombinant anti-EGFR human/murine chimeric monoclonal antibody injection	-

Primary Outcome Measures

Name	Time	Method
AUC0-inf	0 to Day 29	Area under the serum concentration-time curve from time 0 to infinity

Secondary Outcome Measures

Name	Time	Method
λz	0 to Day 29	Apparent terminal elimination rate constant
CL	0 to Day 29	Total clearance
Cmax	0 to Day 29	Maximum serum concentration
Tmax	0 to Day 29	Time to reach maximum serum concentration

Trial Locations

Locations (1)

Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China