CTRI/2025/04/085328尚未招募1 期
A randomized, double-blind, three-arm, balanced, single-dose, parallel-group study comparing pharmacokinetics of Pertuzumab (420 mg solution for Infusion) of Intas Pharmaceuticals Limited, India with Perjeta® of Genentech Inc, A member of Roche Group, USA and Perjeta of Roche Pharma AG, Germany in normal, healthy, adult, human male subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- To prove the bioequivalence of Pertuzumab biosimilar ( 420 mg)
研究概览
简要总结
Primary Objective is to prove the bioequivalence of Pertuzumab biosimilar ( 420 mg) (Test) with that of US-licensed Perjeta® and EU-licensed Perjeta and secondary Objective is to compare safety, tolerability and immunogenicity of Pertuzumab biosimilar (Test) with that of US-licensed Perjeta and EU-licensed Perjeta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Non smoker, normal, healthy, adult, human male subjects greater than or equal to 18 to less than or equal to 45 years of age (both inclusive) 2) Having a body mass index (BMI) between 18.5 and 29.9 (both inclusive), kg per m2 and weighing between 60 kg and 94.9 kg (both inclusive).
- •Not having any significant disease or abnormal findings during screening, medical history, clinical examination, vital sign examination (Pulse rate, blood pressure, Respiratory rate and body temperature), laboratory evaluations, 12- lead ECG, cardiac markers (N-terminal pro-brain natriuretic peptide, troponin I), left ventricular ejection fraction (LVEF) greater than 55 percentage by echocardiogram, TMT, Echocardiogram and X-ray chest (P A view; within the last 6 months) recordings.
- •Has the willingness to adhere to the protocol requirements.
- •Able to understand and comply with the study procedures, as per the opinion of the Principal Investigator.
- •Able to give voluntary written informed consent for participation in the trial.
- •Agree to provide a written assurance to use barrier method (condoms) during the study and even after discontinuation of study till 5 months after the dose of the study 8) Agree to assure that he will not donate semen for 5 months, after participation in the study.
排除标准
- •Known hypersensitivity or idiosyncratic reaction to Pertuzumab or its constituents.
- •History or presence of any disease or disorder known to compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •Significant illness including infection within 4 weeks prior to initial dosing.
- •Any clinically significant laboratory finding at the time of screening including a) ANC (absolute neutrophil count) less than 2000 per mm3 b) Platelet less than 150,000 per mm3 c) Hemoglobin level less than 11.1 g per dL d) Liver function test [alanine aminotransferase and aspartate aminotransferase (ALT and AST) greater than or equal to 1.5 into upper limit normal (ULN) and alkaline phosphatase greater than or equal to 1.5 into ULN, total bilirubin greater than 1.5 mg per dL] e) Renal function test [blood urea nitrogen greater than or equal to 1.5 into institutional normal and creatinine greater than ULN] 5) Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAID-induced urticaria.
- •Previously received any monoclonal antibody or fusion protein within 6 months prior to receiving the dose of the study medicine 7) Smokers, or who have smoked, or use of tobacco or tobacco-containing products (gutkha, pan or pan masala others) within last six months prior to start of the study.
- •Ingestion or use of a medicine (prescribed and over the counter (OTC) medication including herbal remedies) at any time within 1 month prior to dosing, use of COVID-19 vaccine from 14 days prior to dosing.
- •In any such case subject selection will be at the discretion of the Principal Investigator.
- •Subject with history of hypertension or systolic BP of greater than 140 mmHg and diastolic BP of greater than 90 mmHg at the time of screening.
- •A recent history of harmful use of alcohol (less than 2 years), ie., alcohol consumption of more than 7 standard drinks per week (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40 percentage distilled spirits, such as rum, whisky, brandy, etc.) or consumption of alcohol or alcoholic products within 72 hours prior to receiving the study drug.
- •Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •Donation of blood (1 unit or 350 mL) or receipt of an investigational drug or product or participation in a drug research study within 6 months prior to receiving the dose of the study medicine.
- •Positive result for human immunodeficiency virus (HIV 1 and or 2) and/or hepatitis screen including HBsAg, Anti HbcIgM and HCV antibodies tests.
- •History or presence of seizure or psychiatric disorders 15) History of cancer including lymphoma, leukaemia and skin cancer.
- •History of surgery or major trauma within 12 weeks prior to receiving study drug or surgery planned during the study 17) History of congestive heart failure 18) An unusual diet, for whatever reason (e.g. low-sodium), for 4 weeks prior to receiving the study medicine.
- •Consumption of grape fruit or grape fruit products within 72 hours prior to receiving study drug.
- •A history of difficulty with donating blood.
- •History of participation in a clinical study of a monoclonal antibody within 6 months prior to receiving the dose of the study medicine 22) Received live vaccine(s) within 30 days prior to dosing.
结局指标
主要结局
To prove the bioequivalence of Pertuzumab biosimilar ( 420 mg)
时间窗: pre infusion (start of infusion or 0.000 hour) and at 0.333, 0.667, 1.000, 2.000, 4.000, | 8.000, 12.000, 24.000 (day 2), 48.000 (day 3), 96.000 (day 5), 168.000 (day 8), 240.000 (day 11), 336.000 (day 15), 504.000 (day 22), 672.000 | (day 29), 840.000 (day 36), 1008.000 (day 43), 1344.000 (day 57), 1680.000 (day 71), 2016.000 (day 85) and 2352.000 (day 99) hours
(Test) with that of US-licensed Perjeta® and EU-licensed Perjeta
时间窗: pre infusion (start of infusion or 0.000 hour) and at 0.333, 0.667, 1.000, 2.000, 4.000, | 8.000, 12.000, 24.000 (day 2), 48.000 (day 3), 96.000 (day 5), 168.000 (day 8), 240.000 (day 11), 336.000 (day 15), 504.000 (day 22), 672.000 | (day 29), 840.000 (day 36), 1008.000 (day 43), 1344.000 (day 57), 1680.000 (day 71), 2016.000 (day 85) and 2352.000 (day 99) hours
次要结局
- To compare safety, tolerability and immunogenicity of(Pertuzumab biosimilar (Test) with that of US-licensed Perjeta®)
研究者
研究点 (1)
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