ACTRN12616000283471尚未招募1 期
Randomized, double-blind, single-dose, 3-arm parallel design comparative pharmacokinetic and safety Phase I study of BAT1706 versus EU-sourced Avastin (Registered Trademark) and US-sourced Avastin (Registered Trademark) administered in healthy subjects
Quintiles Pty Ltd0 个研究点目标入组 129 人开始时间: 2016年3月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 129
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
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- Male
入选标准
- •1.Adult males aged 18 to 50 years inclusive and between 19 and 28 kg/m2 body mass index (BMI) and body weight greater than and equal to 65 and less than and equal to 100 kg.
- •2.Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead electrocardiogram (ECG).
- •3.Subjects whose clinical laboratory test results are normal, or where outside the reference range are judged as not clinically relevant.
- •4.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 <10 pack year smoking history.
- •5.Must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception such as an intra-uterine device, barrier method with spermicide, oral contraceptive, injectable progesterone, sub-dermal implant, or a bilateral tubal ligation, unless their partners are infertile from the time of the administration of investigational product (IP) until completion of study procedures.
- •6.Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures including standardised meals.
排除标准
- •1.Have a history of and/or current clinically significant gastrointestinal (including diverticulitis, stomach ulcers), renal, hepatic, cardiovascular, haematological (including pancytopenia, aplastic anaemia or blood dyscrasia), pulmonary, neurologic, metabolic (including known diabetes mellitus), psychiatric or allergic disease excluding mild asymptomatic seasonal allergies.
- •2.Subject with a psychiatric disorder or considered unsuitable for inclusion by the investigator (e.g., inability to understand and/or comply with study requirements or presence of any condition which, in the opinion of the investigator, would not allow safe participation in the study).
- •3.History or current clinically significant (in the opinion of the Investigator) allergy, excluding mild asymptomatic seasonal allergies, hypersensitivity or allergic reactions including known or suspected drug hypersensitivity to any component of the study drug formulations (e.g. hypersensitivity to any recombinant human or humanized antibodies) or comparable drugs.
- •4.Any inherited predisposition to bleeding or to thrombosis or history of non-traumatic hemorrhage (i.e. any hemorrhage requiring medical intervention), thromboembolic event or any condition which may increase bleeding risk including clotting disorders, thrombocytopenia (platelet count <150, 000 per micro Litre) or an international normalized ratio higher than 1.5 at screening.
- •5.History of cancer including lymphoma, leukemia and skin cancer.
- •6.Intended participation in contact/collision sports from admission until Day 30.
- •7.Live virus vaccination within 12 weeks prior to screening or intention to receive live virus vaccination during the study until the final follow-up visit.
- •8.Prior exposure to any Investigational drug in any clinical trial within 3 months of study drug administration 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.
- •9.Any prior exposure to bevacizumab or VEGF targeted treatment.
- •10.Any biological drug within 3 months or monoclonal antibodies within 9 months of study drug administration.
- •11.Intake of prescribed or over-the-counter drugs including non-steroidal anti-inflammatory drugs (NSAID) within 14 days or 5 half-lives (whichever is longer) prior to study drug administration. Any dose of aspirin in the last 14 days before administration of the study drug and for the duration of the study is not allowed.
- •12.Intake of herbal remedies within 14 days prior to study drug administration.
- •13.Blood or blood product donation >500 mL in the 1 month before screening or the intention to donate blood or blood products during the study (through Day 99).
- •14.Abnormal and clinically relevant (in the opinion of the Investigator) ECG or corrected QT value (Bazett correction) longer than 450 ms.
- •15.Subjects with abnormal blood pressure (systolic blood pressure less than and equal to 90 and greater than and equal to 140 mmHg, diastolic blood pressure less than and equal to 50 and greater than and equal to 90 mmHg) or pulse rate less than and equal to 45 and greater than and equal to 100 bpm at screening or admission to the clinical center (Day -1).
- •16.Subjects with known hypertension or relevant family history of hypertension, or history of relevant orthostatic hypotension, fainting spells, or blackouts
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