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F901318 Single Ascending Dose Study in Healthy Male Volunteers

Primary Purpose

Invasive Aspergillosis

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

F901318

Placebo

About this trial

This is an interventional treatment trial for Invasive Aspergillosis focused on measuring First in man, Antifungal, Intravenous infusion, Healthy volunteers

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Simbec Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

F901318 0.25 mg/kg

0.25 mg/kg placebo

F901318 0.75 mg/kg

Placebo 0.75 mg/kg

F901318 1.5 mg/kg

Placebo 1.5 mg/kg

F901318 mg/kg

Placebo 3 mg/kg

F901318 5 mg/kg

Placebo 5 mg/kg

Arm Description

Single intravenous infusion over 4 hours

Outcomes

Primary Outcome Measures

Number of Subjects With Adverse Events

Adverse events will be collected from the time of screening until the final study visit

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02142153

First Posted

May 13, 2014

Last Updated

August 10, 2015

Sponsor

F2G Biotech GmbH

Collaborators

Simbec Research

1. Study Identification

Unique Protocol Identification Number

NCT02142153

Brief Title

F901318 Single Ascending Dose Study in Healthy Male Volunteers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

F2G Biotech GmbH

Collaborators

Simbec Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Invasive Aspergillosis

Keywords

First in man, Antifungal, Intravenous infusion, Healthy volunteers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

F901318 0.25 mg/kg

Arm Type

Experimental

Arm Description

Single intravenous infusion over 4 hours

Arm Title

0.25 mg/kg placebo

Arm Type

Placebo Comparator

Arm Description

Single intravenous infusion over 4 hours

Arm Title

F901318 0.75 mg/kg

Arm Type

Experimental

Arm Description

Single intravenous infusion over 4 hours

Arm Title

Placebo 0.75 mg/kg

Arm Type

Placebo Comparator

Arm Description

Single intravenous infusion over 4 hours

Arm Title

F901318 1.5 mg/kg

Arm Type

Experimental

Arm Description

Single intravenous infusion over 4 hours

Arm Title

Placebo 1.5 mg/kg

Arm Type

Placebo Comparator

Arm Description

Single intravenous infusion over 4 hours

Arm Title

F901318 mg/kg

Arm Type

Experimental

Arm Description

Single intravenous infusion over 4 hours

Arm Title

Placebo 3 mg/kg

Arm Type

Placebo Comparator

Arm Description

Single intravenous infusion over 4 hours

Arm Title

F901318 5 mg/kg

Arm Type

Experimental

Arm Description

Single intravenous infusion over 4 hours

Arm Title

Placebo 5 mg/kg

Arm Type

Placebo Comparator

Arm Description

Single intravenous infusion over 4 hours

Intervention Type

Drug

Intervention Name(s)

F901318

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Subjects With Adverse Events

Description

Adverse events will be collected from the time of screening until the final study visit

Time Frame

Single dose

Secondary Outcome Measure Information:

Title

Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities

Description

Number of subjects with significant Clinical safety labs and ECG abnormalities as judged by the investigator from screening until final study visit

Time Frame

Single dose

Other Pre-specified Outcome Measures:

Title

Pharmacokinetics

Description

Blood samples (6 mL) for analysis of F901318 plasma concentration will be drawn pre-dose and at 1h, 2h, 3h and 4h and then 4.25, 4.5, 5.0, 5.5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours following the start of the infusion. (20 samples).

Time Frame

Single dose

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Salvatore Febbraro, MD

Organizational Affiliation

Simbec Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Simbec Research

City

Merthyr Tydfil

State/Province

Mid Glamorgan

ZIP/Postal Code

CF48 4DR

Country

United Kingdom

12. IPD Sharing Statement

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F901318 Single Ascending Dose Study in Healthy Male Volunteers

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