Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects (ORALMAD)

Double blind, placebo controlled, ascending multiple (10) oral dose, sequential group study. Twenty-four subjects will complete the study in 3 cohorts (Groups A to C), each group consisting of 8 subjects. Each cohort will consist of 4 male and 4 female subjects. Each subject will be dosed for 10 days and will be on study for approximately 7 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 15 (120 hours post the last dose). The dose will range between 2 and 10 mg/kg daily, given as either a single daily dose or as two doses divided over the 24-hour dosing period.

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

Cohorts will be dosed at least at 3 weekly intervals. There will be a review of the safety and pharmacokinetic data of each cohort prior to each dose escalation.

 

Condition Intervention Phase
Invasive Aspergillosis Drug: F901318 Dose level A oral
Drug: Placebo dose level A oral
Drug: F901318 Dose level B oral
Drug: Placebo dose level B oral
Drug: F901318 Dose level C oral
Drug: Placebo Dose level C oral
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, Multiple Ascending Oral Dose Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects

Antifungal name: 

Date of article/Start date of trial: 

Wednesday, March 23, 2016

Trial phase: 

Phase 1

ClinicalTrials.gov ID: 

NCT02737371

Trial status: 

Active

Computed content type (New antifungal): 

New antifungal drugs