F901318 Single Ascending Dose Study in Healthy Male Volunteers

NCT ID: NCT02142153

Last Updated: 2015-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-10-31

Brief Summary

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

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.

Conditions

Invasive Aspergillosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

F901318 0.25 mg/kg

Single intravenous infusion over 4 hours

Group Type: EXPERIMENTAL

F901318

Intervention Type: DRUG

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile

0.25 mg/kg placebo

Single intravenous infusion over 4 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

F901318 0.75 mg/kg

Single intravenous infusion over 4 hours

Group Type: EXPERIMENTAL

F901318

Intervention Type: DRUG

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile

Placebo 0.75 mg/kg

Single intravenous infusion over 4 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

F901318 1.5 mg/kg

Single intravenous infusion over 4 hours

Group Type: EXPERIMENTAL

F901318

Intervention Type: DRUG

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile

Placebo 1.5 mg/kg

Single intravenous infusion over 4 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

F901318 mg/kg

Single intravenous infusion over 4 hours

Group Type: EXPERIMENTAL

F901318

Intervention Type: DRUG

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile

Placebo 3 mg/kg

Single intravenous infusion over 4 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

F901318 5 mg/kg

Single intravenous infusion over 4 hours

Group Type: EXPERIMENTAL

F901318

Intervention Type: DRUG

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile

Placebo 5 mg/kg

Single intravenous infusion over 4 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

Interventions

F901318

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile

Intervention Type: DRUG

Placebo

Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-90 kg inclusive

2. 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)

3. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria

1. 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

2. 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

3. 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

4. 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

5. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Simbec Research

INDUSTRY

Sponsor Role: collaborator

F2G Biotech GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salvatore Febbraro, MD

Role: PRINCIPAL_INVESTIGATOR

Simbec Research

Locations

Simbec Research

Merthyr Tydfil, Mid Glamorgan, United Kingdom

Countries

United Kingdom

Other Identifiers

2014-000823-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

F901318-01-01-14

Identifier Type: -

Identifier Source: org_study_id