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.
| Condition | Intervention | Phase |
|---|---|---|
| Invasive Aspergillosis | Drug: F901318 Dose level A oral Drug: Placebo dose level A oral Drug: F901318 Dose level B oral Drug: Placebo dose level B oral Drug: F901318 Dose level C oral Drug: Placebo Dose level C oral |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | F901318 – A Phase I, Double-Blind, Placebo Controlled, Multiple Ascending Oral Dose Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects |
Date of article/Start date of trial: 23 March 2016
Trial Phase: Phase 1
clinical Trials Gov ID: NCT02737371
Trial status: Active