Conditions: Invasive Aspergillosis
Keywords: First in man Antifungal Intravenous infusion Healthy volunteers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: yes

Brief summary:
F901318 is a potent new antifungal agent for the treatment of systemic fungal infections. This study will test it for the first time in man with the objective of assessing its safety, tolerability and pharmacokinetic profile.

Detailed description:
Double blind, placebo controlled, ascending single intravenous dose, sequential group study. Forty subjects will be studied in 5 cohorts (Groups A to E), each group consisting of 8 subjects. Each subject will be on study for approximately 6 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 6 (120 hours post-dose). Each cohort will be dosed in a leading edge design in which two subjects will receive study drug (1 active and 1 placebo) on the first dosing day, and the last 6 will receive study drug (active or placebo) on the second dosing day.

All subjects will return for a post-study visit 8 to 10 days after the dose of study medication.

Cohorts will be dosed at 2 weekly intervals. There will be a review of safety and pharmacokinetic data prior to each dose escalation.

Arms:
arm 1: Single intravenous infusion over 4 hours arm 2: Single intravenous infusion over 4 hours arm 3: Single intravenous infusion over 4 hours arm 4: Single intravenous infusion over 4 hours arm 5: Single intravenous infusion over 4 hours arm 6: Single intravenous infusion over 4 hours arm 7: Single intravenous infusion over 4 hours arm 8: Single intravenous infusion over 4 hours arm 9: Single intravenous infusion over 4 hours arm 10: Single intravenous infusion over 4 hours

Interventions: intervention 1: F901318 intervention 2: Placebo
Intervention descriptions: intervention 1: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile intervention 2: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

Protocol document: