drugset / Trial / NCT02342574

F901318 Multiple Ascending Dose Study

NCT02342574

Phase 1 Completed 72 enrolled F2G Ltd Hammersmith Medicines Research · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2015-02
Primary completion
2016-09
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Olorofim Small molecule 1.5 mg/kg
Subject Olorofim Small molecule 3 mg/kg
Subject Olorofim Small molecule 4 mg/kg