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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: EGFR Overexpression
• Intervention / Treatment: Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection

• Study Type: Interventional
• Enrollment (Estimated): 268
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLX05	Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection; a single dose，250 mg/m2
Active Comparator: EU-sourced Erbitux	Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection; a single dose，250 mg/m2
Active Comparator: US-sourced Erbitux	Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection; a single dose，250 mg/m2
Active Comparator: CN-sourced Erbitux	Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection; a single dose，250 mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-inf	Area under the serum concentration-time curve from time 0 to infinity	0 to Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum serum concentration	0 to Day 29
Tmax	Time to reach maximum serum concentration	0 to Day 29
CL	Total clearance	0 to Day 29
λz	Apparent terminal elimination rate constant	0 to Day 29

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: HLX05-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No