Double blind, placebo controlled, parallel group ascending dose study evaluating single and multiple (x8 days) dose levels of F901318 in groups of male healthy subjects with the objective of defining a dosing schedule for phase ll clinical trials. F901318, a novel and potent antifungal agent for the treatment of invasive aspergillosis, will be delivered intravenously in a range of dosing schedules driven by pharmacokinetic evaluation in real time. Safety and tolerability of those schedules will also be assessed.
| Condition | Intervention | Phase |
|---|---|---|
| Invasive Aspergillosis | Drug: F901318 Drug: Placebo |
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, Single and Multiple Ascending Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects |
Date of article/Start date of trial: 15 January 2015
Trial Phase: Phase 1
clinical Trials Gov ID: NCT02342574
Trial status: Active