PK Evaluation of Intravenous F901318 in healthy volunteers (QCL117986)
Research type
Research Study
Full title
F901318 - A PHASE I, SINGLE INTRAVENOUS DOSE, SAFETY, TOLERABILITY AND PHARMACOKINETIC STUDY IN HEALTHY MALE AND FEMALE SUBJECTS
IRAS ID
222662
Contact name
Anthony Kennedy
Contact email
Sponsor organisation
F2G Limited
Eudract number
2017-000138-69
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 0 months, 20 days
Research summary
The Sponsor is developing the study drug, F901318, for the potential treatment of fungal infections. A particular fungal infection that the drug could treat is called Invasive Aspergillosis which is an often fatal infection that occurs in patients where the immune system is suppressed.
The study is being conducted to measure the level of F901318 in the blood over time after it is given intravenously (directly into a vein in the arm). Safety and tolerability of the F901318 intravenous formulation will also be assessed.
The study will consist of one treatment period involving up to eight healthy male and female subjects. All subjects will be given the study drug intravenously (directly into the arm). The exact dose subjects receive will be dependent on body weight; they will receive 4mg per kg of body weight. Subjects will remain resident in the clinical unit until the morning of Day 4. Safety assessments will be made and blood samples will be taken at regular intervals up until this point. Subjects will attend the clinical unit for two return visits to provide blood samples at 96 and 120 hours post dose. Subjects will also attend a follow-up visit 8-10 days after they were dosed to ensure their continued wellbeing.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0135
Date of REC Opinion
23 Mar 2017
REC opinion
Favourable Opinion