CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
F901318 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02142153
NCT02142153Phase 1Completed

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

F2G Ltd·interventional·Posted May 20, 2014·Updated Sep 7, 2015

In Brief

A Phase 1 clinical trial evaluating F901318 and Placebo for Invasive Aspergillosis. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
CollaboratorsSimbec Research

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 20, 2014
Enrollment StartAug 1, 2014
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.1 years ago

Interventions

F901318drug

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile

Placebodrug

Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities