F901318 Multiple Ascending Dose Study

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

Antifungal name: 

Date of article/Start date of trial: 

Thursday, January 15, 2015

Trial phase: 

Phase 1

ClinicalTrials.gov ID: 

NCT02342574

Trial status: 

Active
New antifungal drugs