Single Ascending Oral Dose Study of F901318
Invasive Aspergillosis
About this trial
This is an interventional treatment trial for Invasive Aspergillosis focused on measuring Single ascending dose, double blind
Eligibility Criteria
Inclusion Criteria:
- Subjects will be males of any ethnic origin between 18 and 45 years of age and with a body weight of 60-100 kg inclusive.
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is acceptable).
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
Exclusion Criteria:
- Male subjects who are not willing to use appropriate contraception (such as a condom) during the study and until follow up.
- Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
- Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical or biological entity) in the past 3 months.
- Subjects who have donated any blood, plasma or platelets in the 2 months prior to screening or who have made donations on more than two occasions within the 12 months preceding the dose administration.
- Subjects with a significant history of drug allergy as determined by the Investigator.
- Subjects who have any clinically significant allergic disease (excluding non-active hay fever) as determined by the Investigator.
- Subjects who have a supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, confirmed by a repeat assessment.
- Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits).
- Subjects with a positive urine drug screen or alcohol breath test result at screening or first admission.
- Subjects must not have smoked for 3 months prior to first dose administration unless otherwise specified by the Investigator or Sponsor.
- Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, ocular (including minor trauma) haematological or other major disorders as determined by the Investigator.
- Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for HIV antibodies.
- Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study, such as QTcB interval >430 msec, 2nd or 3rd degree atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolff-Parkinson-White Syndrome, defined as PR<110 msec, confirmed by a repeat ECG.
- Subjects who, in the opinion of the Investigator, should not participate in the study for any other reason.
Sites / Locations
- Simbec Orion
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Cohort A active
Cohort A placebo
Cohort B active
Cohort B placebo
Cohort C active
Cohort C placebo
Cohort D active
Cohort D placebo
Cohort E active
Cohort E placebo
2 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics
Matching placebo safety,placebo tolerability and placebo pharmacokinetics
4 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics
Matching placebo safety,placebo tolerability and placebo pharmacokinetics
6 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics
Matching placebo safety,placebo tolerability and placebo pharmacokinetics
8 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics
Matching placebo safety,placebo tolerability and placebo pharmacokinetics
10 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics
Matching placebo safety,placebo tolerability and placebo pharmacokinetics