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

Shanghai Henlius Biotech1 个研究点分布在 1 个国家目标入组 268 人2024年4月22日

适应症EGFR Overexpression

干预措施recombinant anti-EGFR human/murine chimeric monoclonal antibody injection

概览

阶段: 1 期
干预措施: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection
疾病 / 适应症: EGFR Overexpression
发起方: Shanghai Henlius Biotech
入组人数: 268
试验地点: 1
主要终点: AUC0-inf
状态: 进行中（未招募）
最后更新: 去年

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2024年4月22日

结束日期

2026年12月31日

最后更新

去年

研究类型

Interventional

研究设计

Parallel

性别

Male

研究者

发起方

Shanghai Henlius Biotech

责任方

Sponsor

入排标准

入选标准

•Males aged 18-50 years (inclusive);
•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;
•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;
•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;
•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.

排除标准

•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;