F901318 Single Ascending Dose Study in Healthy Male Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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Double blind, placebo controlled, ascending single intravenous dose, sequential group study. Forty subjects will be studied in 5 cohorts (Groups A to E), each group consisting of 8 subjects. Each subject will be on study for approximately 6 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 6 (120 hours post-dose). Each cohort will be dosed in a leading edge design in which two subjects will receive study drug (1 active and 1 placebo) on the first dosing day, and the last 6 will receive study drug (active or placebo) on the second dosing day. All subjects will return for a post-study visit 8 to 10 days after the dose of study medication. Cohorts will be dosed at 2 weekly intervals. There will be a review of safety and pharmacokinetic data prior to each dose escalation.

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

Conditions
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Invasive Aspergillosis

Intervention / Treatment
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* Drug: F901318
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-90 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, or whose partners are not willing to use appropriate contraception (such as a condom) with established use of oral, injected or implanted hormonal contraceptive, intrauterine device or diaphragm with spermicide for three months after the last dose Subjects who have received any prescribed systemic or topical medication within 14 days of dosing with study drug 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 dosing with study drug (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 dosing with study drug 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F901318 0.25 mg/kg<br>Single intravenous infusion over 4 hours | Drug: F901318<br>* Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile<br>|
| Placebo Comparator: 0.25 mg/kg placebo<br>Single intravenous infusion over 4 hours | Drug: Placebo<br>* Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities<br>|
| Experimental: F901318 0.75 mg/kg<br>Single intravenous infusion over 4 hours | Drug: F901318<br>* Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile<br>|
| Placebo Comparator: Placebo 0.75 mg/kg<br>Single intravenous infusion over 4 hours | Drug: Placebo<br>* Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities<br>|
| Experimental: F901318 1.5 mg/kg<br>Single intravenous infusion over 4 hours | Drug: F901318<br>* Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile<br>|
| Placebo Comparator: Placebo 1.5 mg/kg<br>Single intravenous infusion over 4 hours | Drug: Placebo<br>* Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities<br>|
| Experimental: F901318 mg/kg<br>Single intravenous infusion over 4 hours | Drug: F901318<br>* Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile<br>|
| Placebo Comparator: Placebo 3 mg/kg<br>Single intravenous infusion over 4 hours | Drug: Placebo<br>* Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities<br>|
| Experimental: F901318 5 mg/kg<br>Single intravenous infusion over 4 hours | Drug: F901318<br>* Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile<br>|
| Placebo Comparator: Placebo 5 mg/kg<br>Single intravenous infusion over 4 hours | Drug: Placebo<br>* Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Adverse Events | Adverse events will be collected from the time of screening until the final study visit | Single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities | Number of subjects with significant Clinical safety labs and ECG abnormalities as judged by the investigator from screening until final study visit | Single dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antifungal, First in man, Intravenous infusion, Healthy volunteers