Invasive AspergillosisPhase 1NCT02142153
F901318 Single Ascending Dose Study in Healthy Male Volunteers
A Phase 1 study testing F901318 in people with Invasive Aspergillosis, run by F2G Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Invasive Aspergillosis
- What is being tested?
- F901318
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec Research
Merthyr Tydfil, Mid Glamorgan, CF48 4DR
About this study
Official title: F901318 - A Phase I, Double-Blind, Placebo Controlled, Single Ascending Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects
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.
Read the 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
- Being tested
- F901318, Placebo
- Keywords
- First in man, Antifungal, Intravenous infusion, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F901318Drug
Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile
PlaceboDrug
Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities
| Study group | Role | What they receive |
|---|---|---|
| F901318 0.25 mg/kg | Experimental | Single intravenous infusion over 4 hours Receives: Drug: F901318 |
| 0.25 mg/kg placebo | Placebo comparator | Single intravenous infusion over 4 hours Receives: Drug: Placebo |
| F901318 0.75 mg/kg | Experimental | Single intravenous infusion over 4 hours Receives: Drug: F901318 |
| Placebo 0.75 mg/kg | Placebo comparator | Single intravenous infusion over 4 hours Receives: Drug: Placebo |
| F901318 1.5 mg/kg | Experimental | Single intravenous infusion over 4 hours Receives: Drug: F901318 |
| Placebo 1.5 mg/kg | Placebo comparator | Single intravenous infusion over 4 hours Receives: Drug: Placebo |
| F901318 mg/kg | Experimental | Single intravenous infusion over 4 hours Receives: Drug: F901318 |
| Placebo 3 mg/kg | Placebo comparator | Single intravenous infusion over 4 hours Receives: Drug: Placebo |
| F901318 5 mg/kg | Experimental | Single intravenous infusion over 4 hours Receives: Drug: F901318 |
| Placebo 5 mg/kg | Placebo comparator | Single intravenous infusion over 4 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Adverse Events
Adverse events will be collected from the time of screening until the final study visit
Measured: Single dose
Secondary outcomes (1)
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
Measured: Single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Invasive AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- F2G Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Salvatore Febbraro, MD, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142153
- Sponsor's protocol ID
- F901318-01-01-14
- Other IDs
- 2014-000823-25, 2014
- Status last verified
- Jun 2015
- First submitted
- 13 May 2014
- Last updated
- 7 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F901318 - A Phase I, Double-Blind, Placebo Controlled, Single Ascending Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02142153
- Acronym / sponsor ID
- F901318-01-01-14
- Conditions
- Invasive Aspergillosis
- Keywords
- First in man, Antifungal, Intravenous infusion, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Posted 7 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| F901318 0.25 mg/kg | Experimental | Drug: F901318Single intravenous infusion over 4 hours |
| 0.25 mg/kg placebo | Placebo comparator | Drug: PlaceboSingle intravenous infusion over 4 hours |
| F901318 0.75 mg/kg | Experimental | Drug: F901318Single intravenous infusion over 4 hours |
| Placebo 0.75 mg/kg | Placebo comparator | Drug: PlaceboSingle intravenous infusion over 4 hours |
| F901318 1.5 mg/kg | Experimental | Drug: F901318Single intravenous infusion over 4 hours |
| Placebo 1.5 mg/kg | Placebo comparator | Drug: PlaceboSingle intravenous infusion over 4 hours |
| F901318 mg/kg | Experimental | Drug: F901318Single intravenous infusion over 4 hours |
| Placebo 3 mg/kg | Placebo comparator | Drug: PlaceboSingle intravenous infusion over 4 hours |
| F901318 5 mg/kg | Experimental | Drug: F901318Single intravenous infusion over 4 hours |
| Placebo 5 mg/kg | Placebo comparator | Drug: PlaceboSingle intravenous infusion over 4 hours |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F901318Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile | Drug | F901318 0.25 mg/kg, F901318 0.75 mg/kg, F901318 1.5 mg/kg, F901318 5 mg/kg, F901318 mg/kg |
| PlaceboComparison of adverse events and clinically sign significant safety lab and ECG abnormalities | Drug | 0.25 mg/kg placebo, Placebo 0.75 mg/kg, Placebo 1.5 mg/kg, Placebo 3 mg/kg, Placebo 5 mg/kg |
Primary outcome
Number of Subjects With Adverse Events
Time frame: Single dose
Adverse events will be collected from the time of screening until the final study visit
1 secondary outcome
Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities
Time frame: Single dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Invasive Aspergillosis
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
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Fungal Status and Prognosis in ABPA
ABPA, Allergic Bronchopulmonary Aspergillosis
RecruitingObservational study
Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
Pneumonia, Fungal Pneumonia
RecruitingObservational study
A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA
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Active, not recruitingObservational study
Liver Cirrhosis Patients With Invasive Pulmonary Aspergillosis: in Depth Understanding Clinical Host Risk Factors
Liver Cirrhosis, Viral Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Febbraro, MD principal investigator
Simbec Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F901318 in people with Invasive Aspergillosis, run by F2G Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Adverse Events (time frame: Single dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.