CTRI/2020/01/022946尚未招募1 期
A randomized, double-blind, parallel, single dose comparative pharmacokinetic study of ZRC-3113 (Zydus Bevacizumab) and ‘Avastin™’ (Bevacizumab) in healthy, adult, male subjects.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- To compare the pharmacokinetics of ZRC-3113 (Zydus Bevacizumab) to ‘Avastin™’ (Bevacizumab) Roche after administration of single intravenous (IV) infusion in healthy, adult, male subjects.
研究概览
简要总结
This is a randomized, double-blind, single dose, two-arm, parallelstudy to compare the pharmacokinetics (PK), immunogenicity and safety of twopreparations of Bevacizumab - namely of ZRC-3113 (Zydus Bevacizumab) and ‘Avastin™’ (Bevacizumab).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age:18 to 45 years old, both inclusive.
- •Sex:Male 3)BMI: 18.5 to 30.0 weight in kg/(height in meter)2 both inclusive 4)Volunteer having body weight of 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) 6)Able to communicate effectively with study personnel.
- •Able to signed and dated written informed consent prior to any study-specific procedures, Willing and able to comply with the study procedures, restrictions and requirements as judged and confirmed by the principal or sub-investigator.
- •Male Volunteers should be willing to use a condom (with spermicide), 02 acceptable contraceptives such as intrauterine device (IUD); oral, transdermal, injected, or implanted contraceptive; condoms; occlusive cap (diaphragm or cervical vault caps); spermicidal foam/gel/cream, etc (with their female partner) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the first day of study medication administration until 6 months after receiving the last administration of study medication [ZRC-3113 (Zydus Bevacizumab), ‘Avastin™’ (Bevacizumab)] administration.
排除标准
- •History of allergic responses/exposure to bevacizumab, Chinese Hamster Ovary (CHO) cell products or other recombinant proteins or antibodies or other related drugs, or antibodies.
- •Participation in a study with Bevacizumab or ‘Avastin™’ (Bevacizumab) or small molecule inhibitors against VEGF or VEGF receptors or any prior exposure to these drugs or any other monoclonal antibody drugs.
- •Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), vital signs, laboratory evaluations, ECG, Echocardiography, ophthalmic examination (slit lamp examination, fundoscopy and tonometry) and chest X-ray recording].
- •Any disease or condition like diabetes, psychosis or others which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, ophthalmic, pulmonary, metabolic, endocrine, immunological, respiratory, central nervous system or any other body system.
- •History or presence of bronchial asthma.
- •Use of any hormone replacement therapy within 3 months prior to the study medication administration.
- •A depot injection or implant of any drug within 3 months prior to the study medication administration.
- •Use of enzyme-modifying drugs within 30 days prior to the study medication administration.
- •History or evidence of drug dependence or of alcoholism or of significant alcohol use.
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •A positive hepatitis screen (includes subtypes B & C).
- •A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
- •Volunteers who have received a known Investigational drug within 03 months of the administered drug prior to the study medication administration or have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
- •Intolerance to venipuncture 15)Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the volunteer’s participation in this study.
- •Institutionalized volunteers.
- •Volunteers have history of perforation, ulcers, gastro oesophageal reflux, inflammatory bowel disease, diverticular disease, or any fistulae.
- •Volunteers have history of nephrotic syndrome.
- •Volunteer having Serum creatinine higher than the upper limit of reference range.
- •Volunteer having any planned surgery or dental procedures within 4 months after administration of Investigational medical product.
- •Volunteers who have history of surgical intervention or injury or dental procedure within 2 months before dosing.
- •Volunteers who have total WBC and neutrophil less than the lower limit of reference range.
- •Volunteers who have albumin present in urine during screening.
- •Volunteers who have history or presence of active bleeding such as recent or recurrent gastrointestinal bleeding, peptic ulcer, due to recent trauma, recent surgery, CNS hemorrhage.
- •Any episode of Hemoptysis or epistaxis within 6 months prior to administration of Investigational Medicinal products.
- •Volunteer having Prothrombin Time, Activated Partial Thromboplastin Time and INR 1.1 times higher than the upper limit of normal range during screening.
- •Volunteers who have presence of a non-healing wound or fracture or wound dehiscence.
- •Volunteers who have medically significant dental disease or dental neglect with signs and or symptoms of local or systemic infection that would likely require a dental procedure during the course of study.
- •Volunteers who have received a live or attenuated vaccine within 3 months prior to screening, or have the intention to receive a vaccine during the study or intend to travel to a region where a vaccination will be required due to endemic disease within 4 months of dosing.
结局指标
主要结局
To compare the pharmacokinetics of ZRC-3113 (Zydus Bevacizumab) to ‘Avastin™’ (Bevacizumab) Roche after administration of single intravenous (IV) infusion in healthy, adult, male subjects.
时间窗: To compare the pharmacokinetics of ZRC-3113 (Zydus Bevacizumab) to ‘Avastin™’ (Bevacizumab) Roche after administration of single intravenous (IV) infusion in healthy, adult, male subjects.
次要结局
- To evaluate the immunogenicity of ZRC-3113 (Zydus Bevacizumab) to ‘Avastin™’ (Bevacizumab) Roche in healthy, adult, male subjects.(Day 0:)
- To assess and compare the safety and tolerability of ZRC-3113 (Zydus Bevacizumab) to ‘Avastin™’ (Bevacizumab) Roche in healthy, adult, male subjects.(Vials:0.5, 1.0, 1.5 (± 15 minutes), 3.0, 8.0, 12.0, 24.0, 36.0, 48.0 and 60.0 hours (± 30 minutes) after start of infusion)
研究者
研究点 (1)
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