Invasive Aspergillosis Clinical Trial
Official title:
F901318 - A Phase I, Single Intravenous Dose, Safety, Tolerability and Pharmacokinetics Study in Healthy Male and Female Subjects
Open label evaluation of a single intravenous dose of F901318 to healthy male and female subjects with pharmacokinetic and safety and tolerability evaluation.
Open label single intravenous dose, single group study. Eight subjects (ideally 4 male and 4
female, minimum of two females) will be studied. The drug product will be a F901318 solution
for infusion (6mg/mL). The dose will be 4 mg/kg delivered in the fasted state (8 hours
minimum) by intravenous infusion over 2 hours. Each subject will be on study for
approximately 6 weeks. Each subject will reside at the Clinical Research Unit (CRU) from Day
-1 (the day before dosing) to Day 4 (72 hours post-dose). Blood samples for pharmacokinetic
evaluation will be obtained up to and including 120 hours post dose. Safety and tolerability
will also be assessed.
Subjects will return to the clinical unit at 96 and 120 hours for pharmacokinetic blood
sampling.
All subjects will return for a post-study visit 8 to 10 days after the dose of study
medication.
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