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

NCT06309043 | Active Not Recruiting Phase 1

• 1 other identifier: HLX05-001
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

EGFR Overexpression

Outcome Measures

Primary Outcomes (1)

• AUC0-inf

  Area under the serum concentration-time curve from time 0 to infinity

  0 to Day 29

Secondary Outcomes (4)

• Cmax

  0 to Day 29

• Tmax

  0 to Day 29

• CL

  0 to Day 29

• λz

  0 to Day 29

Study Arms (4)

HLX05

EXPERIMENTAL

Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection

EU-sourced Erbitux

ACTIVE COMPARATOR

Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection

US-sourced Erbitux

ACTIVE COMPARATOR

Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection

CN-sourced Erbitux

ACTIVE COMPARATOR

Drug: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection

Interventions

recombinant anti-EGFR human/murine chimeric monoclonal antibody injection DRUG

a single dose，250 mg/m2

CN-sourced Erbitux; EU-sourced Erbitux; HLX05; US-sourced Erbitux

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• 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;
• 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;
• Those with hereditary bleeding tendency or coagulation disorder, or a history of thrombosis or bleeding disorders;
• With known or suspected history of keratitis, ulcerative keratitis, or severe dry eye disease;
• With a history of surgery within 3 months prior to screening, or planned surgery during the trial;
• Intolerant to venipuncture or with a history of needle or blood phobia;
• With a history of drug abuse within 6 months prior to screening;
• Use of narcotics within 3 months prior to screening;
• 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;
• Subjects who have received anti-EGFR targeted drugs (including monoclonal antibodies and TKIs) or other monoclonal antibodies within 3 months prior to screening;

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: April 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)