Clinical trial NCT06309043: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: EGFR Overexpression
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2024-03-13
Enrollment: 268
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: AUC0-inf
timeFrame: 0 to Day 29
Secondary outcomes:
measure: Cmax
timeFrame: 0 to Day 29
measure: Tmax
timeFrame: 0 to Day 29
measure: CL
timeFrame: 0 to Day 29
measure: λz
timeFrame: 0 to Day 29
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
References: