CTRI/2023/06/054131尚未招募Unknown
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 & Perjeta of Roche Pharma AG, Germany in normal, healthy, adult, human male subjects - Nil.
Intas Pharmaceuticals Ltd Biopharma Division0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Normal, healthy, adult, human male subjects greater than 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 kg I m2 (both inclusive) and weighing between 60 kg and 94.9 kg (both inclusive).
- •3. 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 1), left ventricular ejection fraction (LVEF) more than 55 percent by echocardiogram , TMT, Echocardiogram and X-ray chest (P-A view, within the last 6 months) recordings.
- •4. Has the willingness to adhere to the protocol requirements.
- •5. Able to understand and comply with the study procedures, as per the opinion of the Principal Investigator.
- •6. Able to give voluntary written informed consent for participation in the trial.
- •7. 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 last 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
- •1. Known hypersensitivity or idiosyncratic reaction to Pertuzumab or its constituents.
- •2. 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.
- •3. Significant illness including infection within 4 weeks prior to initial dosing.
- •4. Any clinically significant laboratory finding at the time of screening Including • ANC (absolute neutrophil count) less than 2000 per mm3, • Platelet less than 150,000 permm3, • Hemoglobin level less than 11 .1 g per dL, • Liver function test (alanine aminotransferase and aspartate aminotransferase (ALT and AST) greater than or equal 1.5 x upper limit normal (ULN) and alkaline phosphatase greater than or equal 1.5 x ULN, total bilirubin greater than or equal 1. 5 mg per dL), • Renal function test (blood urea nitrogen greater than or equal 1. 5 x institutional normal and creatinine more than ULN).
- •5. Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAlD-induced urticaria.
- •6. 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 within last six months prior to start of the study.
- •8. Ingestion or use of a medicine (prescribed and over the counter (OTC) medication including herbal remedies) at any time within 1 month prior to receiving dose. In any such case subject selection will be at the discretion of the Principal Investigator.
- •9. Subject with history of hypertension or systolic BP of more than 140 mmHg and diastolic BP of more than 90 mmHg at the time of screening (reconfirmed
- •at check-in).
- •10. A recent history of harmful use of alcohol (less than 2 years), i.e., 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 percent distilled spirits, such as rum, whisky, brandy, etc.) or consumption of alcohol or alcoholic products within 72 hours prior to receiving the study drug.
- •11 . Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •12. 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.
- •13. Positive result for human immunodeficiency virus (HIV 1 and/or 2) and or hepatitis screen including HBsAg, Anti HBclgM and HCV antibodies tests.
- •14. History or presence of seizure or psychiatric disorders.
- •15. History of cancer including lymphoma, leukaemia and skin cancer.
- •16. 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. In any such case, subject selection will be at the discretion of the Principal Investigator.
- •19. Consumption of grape fruit or grape fruit products within 72 hours prior to receiving study drug.
- •20. A history of difficulty with donating blood.
- •21. History of participation in a clinical study of a monoclonal antibody within 6 months prior to re
研究者
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