NCT02142153

F901318 Single Ascending Dose Study in Healthy Male Volunteers

F901318 - A Phase I, Double-Blind, Placebo Controlled, Single Ascending Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: F2G Biotech GmbH · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Invasive Aspergillosis

Interventions

Type	Name	Description
DRUG	F901318	Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile
DRUG	Placebo	Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-05-20
• Last updated: 2015-09-07
• Results posted: 2015-09-07

Locations

1 site across 1 country: United Kingdom