A Randomized, Double Blind, Parallel, Active Controlled Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta With Trastuzumab (Roche) in Healthy, Adult Subjects by Single IV Infusion Under Fasting Condition
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cmax
研究概览
简要总结
Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2). Trastuzumab is used to treat HER2-positive breast, gastroesophageal, and gastric cancers. HER2 regulate cell growth and survival, as well as adhesion, migration, differentiation and other cellular response. But when HER2 signaling is over expressed it causes uncontrolled cell growth which leads to the formation of cancerous tumor.
详细描述
In this study, healthy adult male volunteers will receive a single intravenous administration of Trastuzumab (Incepta) or Trastuzumab (Roche) according to randomization. During the course of the study, the pharmacokinetics will be assessed by sampling the levels of the drug in the blood and by comparing these levels among the different administration arms. Safety and immunologic response will also be evaluated throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Subjects will be administered either the Test or Reference product, according to the randomization schedule. The test and reference product will be assigned with the randomization code A and B respectively.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male participant, age 18 to 55 years old
- •BMI 18.5 to 30.0 weight in kg/height in meter2; BMI value should be rounded off to one significant digit after decimal point. Volunteer having body weight at least 50 Kg.
- •Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study)
- •Able to understand procedure, agree to participate and willing to give informed consent.
- •Willing and able to comply with the study procedures, restrictions and requirements as judged and confirmed by the principal investigator
- •Male subjects, if married, must agree that they and their spouse will use adequate contraception or be of non-childbearing potential.
排除标准
- •Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, vital signs, laboratory evaluations, ECG, Echocardiography (LVEF less than 55%)]. Any disease or condition like diabetes, psychosis or others which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, ophthalmic, pulmonary, metabolic, endocrine, immunological, respiratory, central nervous system or any other body system.
- •History of and/or current cardiac disease
- •Neutrophil count less than the lower limit of normal range during screening.
- •A positive hepatitis screen (includes subtypes B & C).
- •Use of hematopoietic growth factors, monoclonal antibodies or immunoglobulins within last 6 months prior to the study medication administration.
- •History of any cancer, including carcinoma in situ
- •Volunteer with history of angina, dyspnea, orthopnea, congestive heart failure or myocardial infarction
- •Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) between Screening and the End of Study visit.
- •History or evidence of drug abuse or of alcoholism or of moderate alcohol use.
研究组 & 干预措施
Trastuzumab (proposed Trastuzumab biosimilar)
40 healthy adult male will get Trastuzumab 150 mg/vial manufactured by Incepta Pharmaceuticals Ltd.
干预措施: Trastuzumab (proposed Trastuzumab biosimilar) (Drug)
Herclon
40 healthy adult male will get Herclon 150 mg/vial manufactured by Roche.
干预措施: Herclon (Drug)
结局指标
主要结局
Cmax
时间窗: 71 days from the starting of infusion
Maximum Observed Drug Concentration In Plasma
AUC0-t
时间窗: 71 days from the starting of infusion
Area Under The Concentration Versus Time Curve Up To The Last Measurable Time Point
AUC0-inf
时间窗: 71 days from the starting of infusion
Area Under The Concentration Versus Time Curve From Time 0 To Infinity
Safety assessment: The number of adverse events will be evaluated and compared between the reference and test drugs groups.
时间窗: 71 days from the starting of infusion
No of adverse events in both reference and test product arm will be assessed and compared by monitoring the presence of any AEs or SAEs throughout the study period.
Immunogenicity assessment: Immunogenicity will be assessed by measuring Anti-Drug Antibodies (ADA) formation.
时间窗: 71 days from the starting of infusion
The incidence of Anti-Drug Antibodies (ADA) formation will be measured by taking blood samples on before treatment (pre-dose) and and on day 71
次要结局
未报告次要终点