ACTRN12621000573853尚未招募1 期
A randomized, double-blind, single-dose, 3-way, parallel-group, comparator-controlled study to evaluate the pharmacokinetic, safety, tolerability, and immunogenicity of BP02 (trastuzumab) compared to Herceptin® (EU approved and US-licensed) in healthy adult male volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 111
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- Male
入选标准
- •1.Signed and dated written informed consent prior to any study-specific procedures, ability to understand, and willingness to comply with the study procedures, restrictions, and requirements as judged and confirmed by the Investigator.
- •2.Healthy adult male subjects, 18 to 65 years (both inclusive) of age at the time of signing informed consent.
- •3.Having body mass index (BMI) between 18 to 30 kg/m2 and body weight between 50 to 100 kg (all inclusive).
- •4.Subjects with no clinically relevant abnormalities detected during baseline history, physical examination and vital signs (blood pressure, pulse rate, body temperature, including respiratory rate) as judged by the Investigator.
- •5.Subjects who are considered healthy as determined by clinically acceptable findings of hematology, biochemistry, coagulation tests, urinalysis, 12-lead ECG, and echocardiogram.
- •6.Subjects with normal thyroid function (subjects on thyroid supplementation therapy will not be eligible) at screening.
- •7.Subjects must refrain from donating sperm or fathering a child during the study and until 9 months after administration of BP02, EU-Herceptin or US-Herceptin administration by agreeing to use (with their female partner) 2 acceptable contraceptives.
- •8.Non-smokers or casual smokers who smoke no more than 5 cigarettes (or equivalent quantity of any other nicotine containing substance) per week. Subject must abstain from smoking 48 hours prior to admission to inpatient component of treatment period.
排除标准
- •Subjects are excluded from the study if any of the following criteria apply:
- •1.Known history of hypersensitivity or allergic reactions to trastuzumab or any of its excipients.
- •2.History of cardiovascular, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological, psychiatric or any other disease which in the opinion of the Investigator would make the subject inappropriate for study participation.
- •3.Abnormal and clinically relevant (in the opinion of the Investigator) ECG, history of angina, exertional dyspnea, orthopnea, congestive heart failure, or myocardial infarction.
- •4.Subjects with LVEF of < 60 % on screening echocardiogram should be excluded from the study.
- •5.Sites are to adhere to local and institutional guidelines for exclusion of subjects with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and suspected coronavirus disease-2019 (COVID-19) infection/testing regarding the enrollment of subjects.
- •6.History of any cancer, including carcinoma in situ.
- •7.Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, or human immunodeficiency virus (HIV) I and II at screening.
- •8.Use of prescription or non-prescription drugs, including herbal and dietary supplements (including St. John’s Wort, grapefruit) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment, unless in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise subject safety.
- •9.Use of hematopoietic growth factors, monoclonal antibodies, or immunoglobulins within 6 months prior to screening or 5 half-lives, whichever is longer.
- •10.Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration.
- •11.Difficulty in blood sampling or difficulty in accessibility of veins.
- •12.Prior history of or current alcohol abuse or excessive intake of alcohol as judged by the Investigator and/or a positive test result in breath alcohol done before check-in.
- •13.Subjects with a history of drug abuse or positive drug test at screening or admission.
- •14.Blood donation within 90 days prior to commencement of study and during the study.
- •15.Participation in an investigational antibody-based study within 6 months (from postdose follow-up) and any other investigational study within 90 days prior to dosing.
- •16.Participation in a study with trastuzumab or HER2 targeted antibody or any prior exposure to these drugs.
- •17.Subjects who, in the opinion of the Investigator, are not likely to complete the study for whatever reason.
- •18. Any persons who are:
- •- an employee of the Principal Investigator, clinical center, contract research organization (CRO) or Sponsor.
- •- a relative of an employee of the clinical center, the Investigators, CRO, or the Sponsor.
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