Phase I, SAD, Safety, Tolerability and PK Study of FG3622

• Research type

  Research Study

• Full title

  FG3622 - A PHASE I, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE ASCENDING ORAL DOSE, SAFETY, TOLERABILITY AND PHARMACOKINETIC STUDY IN HEALTHY MALE SUBJECTS

• IRAS ID

  37768

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  F2G Ltd

• Eudract number

  2009-017185-22

• ISRCTN Number

  1

• Research summary

  The purpose of this study is to investigate the safety, tolerability and pharmacokinetic profile of a new drug called FG3622. We will also be looking at how the body's affected by FG3622. We will do this by taking blood samples to measure levels of FG3622 and chemicals called cortisol, ACTH,renin and aldosterone that are found naturally in the body. We will also monitor subjects physical well being and, in particular, the effect of FG3622 on the surface of the eyes.FG3622 is being developed for the treatment of human mycoses (a fungal infection of the human body). FG3622 works in a different way to the other antifungal drugs: it is thought to work by inhibiting a process in the body which is important for controlling the rate at which the fungus is able to grow. Invasive Aspergillosis (IA) is an infection that occurs in patients who have a suppressed immune system (e.g. patients who have received bone marrow or solid organ transplants, and patients with advanced AIDS). IA progresses rapidly and is often fatal, having a mortality rate of 30-95%, despite current therapies. Current treatment choices for IA are limited and many of the drugs currently available for treatment have undesirable characteristics. As a result, there is a need to develop a treatment that will be highly effective but without the undesirable characteristics associated with the treatments currently available. FG3622 is being developed for this purpose. It is hoped that this new drug will be able to replace existing treatment by being both highly effective and safe.

• REC name

  Wales REC 2

• REC reference

  09/WSE02/62

• Date of REC Opinion

  11 Dec 2009

• REC opinion

  Favourable Opinion