F901318 Multiple Ascending Dose Study
F901318 - A Phase I, Double-Blind, Placebo Controlled, Single and Multiple Ascending Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects
研究概览
详细说明
Double blind, placebo controlled, ascending single and multiple intravenous dose, sequential group study. This will be a study in two parts. In the first part, up to twenty four subjects will complete the study in up to 3 cohorts (Groups A to C), each group consisting of 8 subjects, six of whom will receive active compound and two will receive placebo for eight days. Each subject will be on study for approximately 7 weeks. Each subject will participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 13 (120 hours post the last dose).
This first part (Part 1) will test doses already evaluated in the previous single ascending dose study (F901318-01-01-14, 0.25-4 mg/kg given over 4 hours). The dose levels for the study are expected to be 1.5, 3 and 4 mg/kg/day given as a four hour infusion once daily.
In the second part of the study (Part 2), doses higher than those previously evaluated may be studied and/or different dosing schedules designed to deliver a maximum tolerated dose over 24 hours. If a dose level higher than those previously studied is chosen, there will be an optional single dose studied initially for safety and pharmacokinetic profile (Part 2A), followed about 14 days later in another group of subjects by exposure at that same dose level over 8 consecutive days (Part 2B). These higher doses may be given in a once or twice daily dosing schedule. Six subjects will receive active compound and two will receive placebo in both the single dose and multiple dose cohorts. The single dose cohorts will receive study drug in a sentinel group design in which two subjects receive study drug (one active and one placebo) on the first day and the rest of the group one day later. There will be a review of safety data by the Principal Investigator and the Medical Monitor after the first two subjects have been dosed and before the last six subjects are dosed in each cohort in part 2A.
In Part 2, up to forty-eight subjects will complete the study in up to 6 cohorts (Part 2A, Groups D1 to F1, single day dosing, and Part 2B, Groups D2 to F2 eight days' dosing). Subjects in Parts 1 and 2B will be on the study for approximately 7 weeks and Part 2A for approximately 8 weeks. Each subject will participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 6 (120 hours after the single dose in Parts 1 and 2A) and from Day -1 (the day before dosing) to Day 13 (120 hours after the first dose in Part 2B). The proposed total daily dose levels for Part 2 will be up to 10 mg/kg/day given either once daily or in two split daily doses. The duration of the infusions will be between 2 and 24 hours which may include a loading dose to achieve therapeutic plasma concentrations as quickly as possible.
All subjects will return for a post-study visit 8 to 10 days after the last dose of study medication.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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UK
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London、UK、英国、NW10 7EW
- Hammersmith Medicines Research
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-100 kg inclusive
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is acceptable)
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
- Subjects must have ophthalmology assessments within the normal limits at screening. This includes normal Meibomian gland function
Exclusion Criteria:
- Male subjects who are not willing to use appropriate contraception (such as a condom) during the study and until follow up
- Subjects who have received any prescribed systemic or topical medication within 14 days of dosing with study drug unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of dosing with study drug (with the exception of vitamin/mineral supplements and paracetamol) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of dosing with study drug unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety
- Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical or biological entity) in the past 3 months since the last dose.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:A active
Six subjects receiving F901318 1.5 mg/kg intravenously for eight days
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Administration of active compound
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安慰剂比较:A placebo
Two subjects receiving F901318 placebo intravenously for eight days
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安慰剂给药
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实验性的:B active
Six subjects receiving F901318 3 mg/kg intravenously for eight days
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Administration of active compound
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安慰剂比较:B placebo
Two subjects receiving F901318 placebo intravenously for eight days
|
安慰剂给药
|
实验性的:C active
Six subjects receiving F901318 4 mg/kg intravenously for eight days
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Administration of active compound
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安慰剂比较:C placebo
Two subjects receiving F901318 placebo intravenously for eight days
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安慰剂给药
|
实验性的:D1 active
Six subjects dosed for one day with F901318 intravenously dose to be determined
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Administration of active compound
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安慰剂比较:D1 placebo
Two subjects receiving F901318 placebo intravenously for one day
|
安慰剂给药
|
实验性的:E1 active
Six subjects dosed for one day with F901318 intravenously dose to be determined
|
Administration of active compound
|
安慰剂比较:E1 placebo
Two subjects receiving F901318 placebo intravenously for one day
|
安慰剂给药
|
实验性的:F1 active
Six subjects dosed for one day with F901318 intravenously dose to be determined
|
Administration of active compound
|
安慰剂比较:F1 placebo
Two subjects receiving F901318 placebo intravenously for one day
|
安慰剂给药
|
实验性的:D2 active
Six subjects dosed for eight days with F901318 intravenously dose to be determined
|
Administration of active compound
|
安慰剂比较:D2 placebo
Two subjects receiving F901318 placebo intravenously for eight days
|
安慰剂给药
|
实验性的:E2 active
Six subjects dosed for eight days with F901318 intravenously dose to be determined
|
Administration of active compound
|
安慰剂比较:E2 placebo
Two subjects receiving F901318 placebo intravenously for eight days
|
安慰剂给药
|
实验性的:F2 active
Six subjects dosed for eight days with F901318 intravenously dose to be determined
|
Administration of active compound
|
安慰剂比较:F2 placebo
Two subjects receiving F901318 placebo intravenously for eight days
|
安慰剂给药
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
safety: adverse events
大体时间:13 days
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adverse events
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13 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
pharmacokinetics AUC
大体时间:13 days
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area under concentration time curve
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13 days
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pharmacokinetics Cmin
大体时间:13 days
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drug level in blood 24 hours after dosing
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13 days
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合作者和调查者
调查人员
- 首席研究员:Frans van den Berg, MB ChB、Hammersmith Medicines Research
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的