A randomized, double-blind, single-dose, 3-way, parallel group, comparator-controlled, adaptive design, pharmacokinetic, safety, and tolerability study in healthy male volunteers to evaluate bioequivalence of CBT124 to Avastin(Registered Trademark) (EU and US)

Cipla BioTec Pvt. Ltd.0 个研究点目标入组 150 人开始时间: 2016年4月4日最近更新: 2020年1月13日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 150

研究概览研究设计入排标准研究者记录与标识符相似试验

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

入排标准

年龄范围: 15 Years 至 50 Years（—）
性别: Male

入选标准

•*Adult healthy male subjects aged 18 to 50 years (inclusive) and between 18.0 and 30.0 kg per sq mtr body mass index (inclusive) and body weight between 60 kg and 100 kg, both inclusive.
•*Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs and 12 lead electrocardiogram (ECG) at screening and admission.
•Subjects whose clinical laboratory test results are normal, or where outside the reference range is judged as not clinically relevant by the Investigator.
•*Have systolic blood pressure between 140 and 90 mmHg both inclusive, diastolic blood pressure 90 and 50 mmHg both inclusive and heart rate 40 and 90 bpm both inclusive at screening and admission. For single measurements in the 141 to 160 mmHg range (systolic) or in the 91 to 100 mmHg range (diastolic), a single repetition on a the same day is allowed and, in this case, the mean of both measurements will guide eligibility. The mean of both the measurements should be 140 mmHg (systolic) and 90 mmHg (diastolic) both inclusive.
•*Have physical examination results without clinically relevant findings at screening and admission.
•*Have 12-lead ECG results without clinically relevant findings at screening and admission.
•*Subjects who are non-smokers and have not regularly used tobacco or nicotine containing products for at least 3 months preceding screening and have a less than 10 pack year smoking history.
•*Males must be willing to use a medically acceptable method of contraception from the time of the administration of investigational product (IP), throughout the study and for a period of 6 months after the administration of the IP. Medically acceptable methods of contraception include the following: abstinence; or willing to use a condom in addition to having their female partner use another form of contraception such as an intra-uterine device, oral contraceptive, injectable progesterone, sub-dermal implant, or a tubal ligation. This requirement may be waived if the Principal Investigator or delegate is satisfied that the subject or subject’s female partner is sterile i.e. if female has undergone hysterectomy or tubal ligation at least 3 months prior to screening or is post-menopausal (no period for at least 12 months prior to screening) or if the subject has undergone vasectomy at least 6 months prior to screening.
•*Must agree not to donate sperm for at least 6 months after the administration of IP.
•*Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures including standardized meal.
•*Must be able to provide informed consent which must be obtained prior to any study related procedures.
•*Subjects who have a negative fecal occult blood test and a negative Helicobacter pylori stool antigen test.
•*Subjects who are willing to comply with the study restrictions, and comply with the scheduled visits from screening and throughout the study.

排除标准

•*Have a history of hypersensitivity or allergic reactions (either spontaneous or following drug administration) to bevacizumab or vascular endothelial growth factor (VEGF) targeted
•treatment or to any of the excipients.
•*Have a history of or presence of current clinically significant gastrointestinal (including diverticulitis, stomach ulcers, inflammatory intestinal disease, gastrointestinal perforations/fistulae/intra-abdominal abscess), any other internal, non gastrointestinal fistulae that is at an increased risk of bleeding), renal, hepatic, cardiovascular, hematological (including pancytopenia, aplastic anaemia or blood dyscrasia), pulmonary, neurologic, metabolic (including known diabetes mellitus), psychiatric or allergic disease excluding mild asymptomatic seasonal allergies.
•*Have a history of and/or current cardiac disease defined as one of the following:
•*History of congestive heart failure;
•*Angina pectoris requiring anti-anginal medication;
•*Evidence of transmural infarction on ECG;
•*History of sustained hypertension (systolic greater than 180 mmHg and/or diastolic greater than 100 mmHg) or hypertensive crisis or hypertension encephalopathy;
•*Clinically significant valvular heart disease; or
•*Severe arterial thromboembolic events.
•*Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, or human immunodeficiency virus (HIV) I and II at screening.
•*Have a history of cancer including lymphoma, leukaemia and skin cancer (including any history of malignancy, even resected basal cell carcinoma or squamous cell carcinoma).
•*Have an illness within 30 days prior to screening, or prior to dosing, that is classed as clinically significant by the Investigator.
•*Prior exposure to any investigational monoclonal antibody within 12 months of study drug administration.
•*Any clinically significant infection, in the opinion of the Investigator, ongoing at screening or admission to the clinical unit.
•*Have had major surgery within 30 days prior to screening, or will have an operation between screening and the end of study visit, or still has an unhealed wound, including wound dehiscence and wound healing complications requiring medical intervention.
•*Have received live vaccine(s) within 30 days prior to screening or will require a live vaccine(s) between screening and the end of study visit.
•*Have an intake of alcoholic beverages of more than 28 units per week (1 unit = 250 mL of beer, 25 mL of spirits or one glass [125 mL] of wine).
•*Have reasonable evidence (in the opinion of the Investigator) of drug abuse as indicated by a positive urinary drug test at screening or admission.
•*Have taken medication with a half-life of more than 24 hours within 30 days or less than 10 half-lives of the medication prior to the administration of the study drug as determined by the Investigator.
•*Have donated more than 100 mL blood within 4 weeks prior to the administration of the study drug. Blood donation and blood products is not permitted throughout study.
•*Have participated in another clinical study of an investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the administration of the study drug, or are currently participating in another clinical study of an investigational drug, or intending to participate in another clinical study of an investigational drug before completion of all scheduled evaluations in this clinical study.
•*Subjects who, i

研究者

发起方

Cipla BioTec Pvt. Ltd.

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