F901318 - A Phase I, Double-Blind, Placebo Controlled, Single Ascending Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Subjects With Adverse Events
研究概览
简要总结
F901318 is a potent new antifungal agent for the treatment of systemic fungal infections. This study will test it for the first time in man with the objective of assessing its safety, tolerability and pharmacokinetic profile.
详细描述
Double blind, placebo controlled, ascending single intravenous dose, sequential group study. Forty subjects will be studied in 5 cohorts (Groups A to E), each group consisting of 8 subjects. Each subject will be on study for approximately 6 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 post-dose). Each cohort will be dosed in a leading edge design in which two subjects will receive study drug (1 active and 1 placebo) on the first dosing day, and the last 6 will receive study drug (active or placebo) on the second dosing day.
All subjects will return for a post-study visit 8 to 10 days after the dose of study medication.
Cohorts will be dosed at 2 weekly intervals. There will be a review of safety and pharmacokinetic data prior to each dose escalation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-90 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
排除标准
- •Male subjects who are not, or whose partners are not willing to use appropriate contraception (such as a condom) with established use of oral, injected or implanted hormonal contraceptive, intrauterine device or diaphragm with spermicide for three months after the last dose
- •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) 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
研究组 & 干预措施
F901318 0.25 mg/kg
Single intravenous infusion over 4 hours
干预措施: F901318 (Drug)
0.25 mg/kg placebo
Single intravenous infusion over 4 hours
干预措施: Placebo (Drug)
F901318 0.75 mg/kg
Single intravenous infusion over 4 hours
干预措施: F901318 (Drug)
Placebo 0.75 mg/kg
Single intravenous infusion over 4 hours
干预措施: Placebo (Drug)
F901318 1.5 mg/kg
Single intravenous infusion over 4 hours
干预措施: F901318 (Drug)
Placebo 1.5 mg/kg
Single intravenous infusion over 4 hours
干预措施: Placebo (Drug)
F901318 mg/kg
Single intravenous infusion over 4 hours
干预措施: F901318 (Drug)
Placebo 3 mg/kg
Single intravenous infusion over 4 hours
干预措施: Placebo (Drug)
F901318 5 mg/kg
Single intravenous infusion over 4 hours
干预措施: F901318 (Drug)
Placebo 5 mg/kg
Single intravenous infusion over 4 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With Adverse Events
时间窗: Single dose
Adverse events will be collected from the time of screening until the final study visit
次要结局
- Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities(Single dose)