F901318 - A Phase I, Double-Blind, Placebo Controlled, Multiple Ascending Oral Dose Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female 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
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability
研究概览
简要总结
Double blind, placebo controlled, ascending multiple (10) oral dose, sequential group study. Twenty-four subjects will complete the study in 3 cohorts (Groups A to C), each group consisting of 8 subjects. Each cohort will consist of 4 male and 4 female subjects. Each subject will be dosed for 10 days and 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 15 (120 hours post the last dose). The dose will range between 2 and 10 mg/kg daily, given as either a single daily dose or as two doses divided over the 24-hour dosing period.
All subjects will return for a post-study visit 8 to 10 days after the last dose of study medication.
Cohorts will be dosed at least at 3 weekly intervals. There will be a review of the safety and pharmacokinetic data of each cohort prior to each dose escalation.
详细描述
Male and female healthy subjects conforming to the selection criteria will be invited to take part in the study.
Screening visit (Visit 1) After giving fully informed, written consent, subjects will attend the clinic.
Subjects will undergo screening within 28 days prior to the first dose administration. Prior to the screening visit, subjects will:
- Refrain from vigorous exercise for 7 days
- Abstain from alcohol for 48 hours
- Subjects will sign the consent form in the presence of a CRU physician prior to any screening procedures being performed. The information recorded for all subjects, regardless of their suitability for the study, will be retained and archived.
The following information and procedures will be recorded and performed as part of the screening assessments:
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
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be males or females of any ethnic origin between 18 and 45 years of age and with a body weight of 50-100 kg inclusive. Females of child bearing potential must be established on a reliable form of contraception and have a negative pregnancy test at screening.
- •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.
排除标准
- •Male or female subjects who are not willing to use appropriate contraception during the study and until 3 months after the last dose.
- •Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration 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 the dose administration (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 the dose administration 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.
- •Subjects who have donated any blood, plasma or platelets in the 3 months prior to screening or who have made donations on more than two occasions within the 12 months preceding the dose administration.
研究组 & 干预措施
F901318 Dose level A oral
F901318 adverse events days 1-10
干预措施: F901318 Dose level A oral (Drug)
Placebo Dose level A oral
Placebo adverse events days 1-10
干预措施: Placebo dose level A oral (Drug)
F901318 Dose level B oral
F901318 adverse events days 1-10
干预措施: F901318 Dose level B oral (Drug)
Placebo Dose level B oral
Placebo adverse events days 1-10
干预措施: Placebo dose level B oral (Drug)
F901318 Dose level C oral
F901318 adverse events days 1-10
干预措施: F901318 Dose level C oral (Drug)
Placebo Dose level C oral
Placebo adverse events days 1-10
干预措施: Placebo Dose level C oral (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability
时间窗: 10 days
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability
次要结局
- Pharmacokinetics Area under concentration/time curve(15 days)