NCT03390673已完成1 期
A Phase I, Double-blind, Randomised, Single-dose, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 4
- 主要终点
- Area under Curve (AUC, Pharmacokinetics)
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics, as well as to evaluate the safety, tolerability and immunogenicity of HD204, US-Avastin and EU-Avastin in healthy male subjects after intravenous administration of a single dose..
详细描述
This is a double-blind, randomized, three-arm, parallel-group, single-dose study. A total of 120 evaluable subjects are required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-smoking healthy male subjects, 18-50 years old inclusive
- •Body Mass index is between 19 to 30 kg/m2, inclusive
- •NO history of hypersensitivity or allergic reaction to the active ingredient, murine proteins, or excipients, spontaneous or following drug administration.
- •For subjects with female partners of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the end of study. Adequate contraception is defined as the usage by the female partner of any form of hormonal contraception or intra-uterine device (which should be established prior to the start of study) plus usage by one of the partners of an additional spermicide-containing barrier method of contraception. The use of a barrier method alone or reliance on abstinence is not considered adequate.
- •Subjects must agree not to donate sperm during the study and for 4 months following treatment with the study medication or until scheduled End Of Study (EOS), whichever is longer.
- •Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.
排除标准
- •Clinically significant abnormalities in physical examination, laboratory test results or electrocardiogram (ECG)
- •Systolic blood pressure > 140 mmHg or < 90 mmHg , or diastolic blood pressure > 90 mmHg or <50 mmHg
- •Proteinuria (with a urine dipstick value of 2+ or above)
- •Coagulation abnormalities ( i.e., INR > 2x ULN)
- •Bleeding diathesis, history of duodenal ulcers, concomitant use of anticoagulants, or any hemorrhage within 6 months prior to study enrollment.
- •Surgical procedure within 2 months of screening, or planned surgical procedure within 2 months of EOS
- •Positive test result for drugs of abuse or alcohol breathing test.
- •Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 or
- •Donated or lost > 500ml of blood in the previous 3 months
- •Taken an investigational drug within 3 months (or 5 half-lives), whichever is longer.
- •Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug or non-prescription drugs (with the exception of paracetamol, which is allowed).
- •Previously received bevacizumab or any product considered to be biosimilar to bevacizumab, or any other antibody or protein targeting VEGF or VEGFR.
- •Unwillingness or inability to comply with the study protocol for any reason.
- •Male subject whose partner is pregnant.
- •History or evidence of a clinically significant disorder (including cardiovascular, cerebrovascular, endocrine or psychiatric), or immunocompromised condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- •History of alcohol and/or drug abuse within 12 months of screening.
研究组 & 干预措施
US-licensed Avastin
Active Comparator
Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
干预措施: Avastin (Drug)
HD204
Experimental
Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
干预措施: HD204 (Drug)
EU-licensed Avastin
Active Comparator
Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
干预措施: Avastin (Drug)
结局指标
主要结局
Area under Curve (AUC, Pharmacokinetics)
时间窗: up to week 12
Sampling will be performed in all patients to compare the PK through values of HD204 and Avastin
Bevacizumab PK Parameter (AUC0-inf)
时间窗: 71 Days
PK blood samples were collected from subjects to determine the AUC0-inf of bevacizumab. Samples were collected from 0 (pre-dose) to 1680 (post-dose) on days 1-74.
次要结局
- Immunogenicity(Days 1 (predose), 15, 22,29, 36, 43, 50, 64, 78 and 95(End of treatment))
- Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)(From Day 1 through study completion (Day 95))
研究者
研究点 (4)
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