Invasive AspergillosisPhase 1NCT02342574
F901318 Multiple Ascending Dose Study
A Phase 1 study testing F901318 in people with Invasive Aspergillosis, run by F2G Ltd at 1 site in United Kingdom.
Trial summary
Double blind, placebo controlled, parallel group ascending dose study evaluating single and multiple (x8 days) dose levels of F901318 in groups of male healthy subjects with the objective of defining a dosing schedule for phase ll clinical trials. 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
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60-100 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
- Subjects must have ophthalmology assessments within the normal limits at screening. This includes normal Meibomian gland function
Who cannot join
- 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 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 and paracetamol) 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 since the last dose.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Medicines Research
London, UK, NW10 7EW
About this study
Official title: F901318 - A Phase I, Double-Blind, Placebo Controlled, Single and Multiple Ascending Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects
Double blind, placebo controlled, parallel group ascending dose study evaluating single and multiple (x8 days) dose levels of F901318 in groups of male healthy subjects with the objective of defining a dosing schedule for phase ll clinical trials. F901318, a novel and potent antifungal agent for the treatment of invasive aspergillosis, will be delivered intravenously in a range of dosing schedules driven by pharmacokinetic evaluation in real time. Safety and tolerability of those schedules will also be assessed.
Read the detailed description
Double blind, placebo controlled, ascending single and multiple intravenous dose, sequential group study. This will be a study in two parts. In the first part, up to twenty four subjects will complete the study in up to 3 cohorts (Groups A to C), each group consisting of 8 subjects, six of whom will receive active compound and two will receive placebo for eight days. Each subject will be on study for approximately 7 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 13 (120 hours post the last dose).
This first part (Part 1) will test doses already evaluated in the previous single ascending dose study (F901318-01-01-14, 0.25-4 mg/kg given over 4 hours). The dose levels for the study are expected to be 1.5, 3 and 4 mg/kg/day given as a four hour infusion once daily.
In the second part of the study (Part 2), doses higher than those previously evaluated may be studied and/or different dosing schedules designed to deliver a maximum tolerated dose over 24 hours. If a dose level higher than those previously studied is chosen, there will be an optional single dose studied initially for safety and pharmacokinetic profile (Part 2A), followed about 14 days later in another group of subjects by exposure at that same dose level over 8 consecutive days (Part 2B). These higher doses may be given in a once or twice daily dosing schedule. Six subjects will receive active compound and two will receive placebo in both the single dose and multiple dose cohorts. The single dose cohorts will receive study drug in a sentinel group design in which two subjects receive study drug (one active and one placebo) on the first day and the rest of the group one day later. There will be a review of safety data by the Principal Investigator and the Medical Monitor after the first two subjects have been dosed and before the last six subjects are dosed in each cohort in part 2A.
In Part 2, up to forty-eight subjects will complete the study in up to 6 cohorts (Part 2A, Groups D1 to F1, single day dosing, and Part 2B, Groups D2 to F2 eight days' dosing). Subjects in Parts 1 and 2B will be on the study for approximately 7 weeks and Part 2A for approximately 8 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 after the single dose in Parts 1 and 2A) and from Day -1 (the day before dosing) to Day 13 (120 hours after the first dose in Part 2B). The proposed total daily dose levels for Part 2 will be up to 10 mg/kg/day given either once daily or in two split daily doses. The duration of the infusions will be between 2 and 24 hours which may include a loading dose to achieve therapeutic plasma concentrations as quickly as possible.
All subjects will return for a post-study visit 8 to 10 days after the last dose of study medication.
- Conditions
- Invasive Aspergillosis
- Being tested
- F901318, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F901318Drug
Administration of active compound
PlaceboDrug
Administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| A active | Experimental | Six subjects receiving F901318 1.5 mg/kg intravenously for eight days Receives: Drug: F901318 |
| A placebo | Placebo comparator | Two subjects receiving F901318 placebo intravenously for eight days Receives: Drug: Placebo |
| B active | Experimental | Six subjects receiving F901318 3 mg/kg intravenously for eight days Receives: Drug: F901318 |
| B placebo | Placebo comparator | Two subjects receiving F901318 placebo intravenously for eight days Receives: Drug: Placebo |
| C active | Experimental | Six subjects receiving F901318 4 mg/kg intravenously for eight days Receives: Drug: F901318 |
| C placebo | Placebo comparator | Two subjects receiving F901318 placebo intravenously for eight days Receives: Drug: Placebo |
| D1 active | Experimental | Six subjects dosed for one day with F901318 intravenously dose to be determined Receives: Drug: F901318 |
| D1 placebo | Placebo comparator | Two subjects receiving F901318 placebo intravenously for one day Receives: Drug: Placebo |
| E1 active | Experimental | Six subjects dosed for one day with F901318 intravenously dose to be determined Receives: Drug: F901318 |
| E1 placebo | Placebo comparator | Two subjects receiving F901318 placebo intravenously for one day Receives: Drug: Placebo |
| F1 active | Experimental | Six subjects dosed for one day with F901318 intravenously dose to be determined Receives: Drug: F901318 |
| F1 placebo | Placebo comparator | Two subjects receiving F901318 placebo intravenously for one day Receives: Drug: Placebo |
| D2 active | Experimental | Six subjects dosed for eight days with F901318 intravenously dose to be determined Receives: Drug: F901318 |
| D2 placebo | Placebo comparator | Two subjects receiving F901318 placebo intravenously for eight days Receives: Drug: Placebo |
| E2 active | Experimental | Six subjects dosed for eight days with F901318 intravenously dose to be determined Receives: Drug: F901318 |
| E2 placebo | Placebo comparator | Two subjects receiving F901318 placebo intravenously for eight days Receives: Drug: Placebo |
| F2 active | Experimental | Six subjects dosed for eight days with F901318 intravenously dose to be determined Receives: Drug: F901318 |
| F2 placebo | Placebo comparator | Two subjects receiving F901318 placebo intravenously for eight days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety: adverse events
adverse events
Measured: 13 days
Secondary outcomes (2)
pharmacokinetics AUC
area under concentration time curve
Measured: 13 days
pharmacokinetics Cmin
drug level in blood 24 hours after dosing
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- F2G Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Responsible party
- Sponsor
- Investigators
- Frans van den Berg, MB ChB, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342574
- Sponsor's protocol ID
- F901318-01-02-14
- Status last verified
- Aug 2016
- First submitted
- 15 Jan 2015
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F901318 - A Phase I, Double-Blind, Placebo Controlled, Single and Multiple Ascending Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02342574
- Acronym / sponsor ID
- F901318-01-02-14
- Conditions
- Invasive Aspergillosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Study start
- Feb 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double blind, placebo controlled, parallel group ascending dose study evaluating single and multiple (x8 days) dose levels of F901318 in groups of male healthy subjects with the objective of defining a dosing schedule for phase ll clinical trials. F901318, a novel and potent antifungal agent for the treatment of invasive aspergillosis, will be delivered intravenously in a range of dosing schedules driven by pharmacokinetic evaluation in real time. Safety and tolerability of those schedules will also be assessed.
Detailed description
Double blind, placebo controlled, ascending single and multiple intravenous dose, sequential group study. This will be a study in two parts. In the first part, up to twenty four subjects will complete the study in up to 3 cohorts (Groups A to C), each group consisting of 8 subjects, six of whom will receive active compound and two will receive placebo for eight days. Each subject will be on study for approximately 7 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 13 (120 hours post the last dose).
This first part (Part 1) will test doses already evaluated in the previous single ascending dose study (F901318-01-01-14, 0.25-4 mg/kg given over 4 hours). The dose levels for the study are expected to be 1.5, 3 and 4 mg/kg/day given as a four hour infusion once daily.
In the second part of the study (Part 2), doses higher than those previously evaluated may be studied and/or different dosing schedules designed to deliver a maximum tolerated dose over 24 hours. If a dose level higher than those previously studied is chosen, there will be an optional single dose studied initially for safety and pharmacokinetic profile (Part 2A), followed about 14 days later in another group of subjects by exposure at that same dose level over 8 consecutive days (Part 2B). These higher doses may be given in a once or twice daily dosing schedule. Six subjects will receive active compound and two will receive placebo in both the single dose and multiple dose cohorts. The single dose cohorts will receive study drug in a sentinel group design in which two subjects receive study drug (one active and one placebo) on the first day and the rest of the group one day later. There will be a review of safety data by the Principal Investigator and the Medical Monitor after the first two subjects have been dosed and before the last six subjects are dosed in each cohort in part 2A.
In Part 2, up to forty-eight subjects will complete the study in up to 6 cohorts (Part 2A, Groups D1 to F1, single day dosing, and Part 2B, Groups D2 to F2 eight days' dosing). Subjects in Parts 1 and 2B will be on the study for approximately 7 weeks and Part 2A for approximately 8 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 after the single dose in Parts 1 and 2A) and from Day -1 (the day before dosing) to Day 13 (120 hours after the first dose in Part 2B). The proposed total daily dose levels for Part 2 will be up to 10 mg/kg/day given either once daily or in two split daily doses. The duration of the infusions will be between 2 and 24 hours which may include a loading dose to achieve therapeutic plasma concentrations as quickly as possible.
All subjects will return for a post-study visit 8 to 10 days after the last dose of study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| A active | Experimental | Drug: F901318Six subjects receiving F901318 1.5 mg/kg intravenously for eight days |
| A placebo | Placebo comparator | Drug: PlaceboTwo subjects receiving F901318 placebo intravenously for eight days |
| B active | Experimental | Drug: F901318Six subjects receiving F901318 3 mg/kg intravenously for eight days |
| B placebo | Placebo comparator | Drug: PlaceboTwo subjects receiving F901318 placebo intravenously for eight days |
| C active | Experimental | Drug: F901318Six subjects receiving F901318 4 mg/kg intravenously for eight days |
| C placebo | Placebo comparator | Drug: PlaceboTwo subjects receiving F901318 placebo intravenously for eight days |
| D1 active | Experimental | Drug: F901318Six subjects dosed for one day with F901318 intravenously dose to be determined |
| D1 placebo | Placebo comparator | Drug: PlaceboTwo subjects receiving F901318 placebo intravenously for one day |
| E1 active | Experimental | Drug: F901318Six subjects dosed for one day with F901318 intravenously dose to be determined |
| E1 placebo | Placebo comparator | Drug: PlaceboTwo subjects receiving F901318 placebo intravenously for one day |
| F1 active | Experimental | Drug: F901318Six subjects dosed for one day with F901318 intravenously dose to be determined |
| F1 placebo | Placebo comparator | Drug: PlaceboTwo subjects receiving F901318 placebo intravenously for one day |
| D2 active | Experimental | Drug: F901318Six subjects dosed for eight days with F901318 intravenously dose to be determined |
| D2 placebo | Placebo comparator | Drug: PlaceboTwo subjects receiving F901318 placebo intravenously for eight days |
| E2 active | Experimental | Drug: F901318Six subjects dosed for eight days with F901318 intravenously dose to be determined |
| E2 placebo | Placebo comparator | Drug: PlaceboTwo subjects receiving F901318 placebo intravenously for eight days |
| F2 active | Experimental | Drug: F901318Six subjects dosed for eight days with F901318 intravenously dose to be determined |
| F2 placebo | Placebo comparator | Drug: PlaceboTwo subjects receiving F901318 placebo intravenously for eight days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 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
- Subjects must have ophthalmology assessments within the normal limits at screening. This includes normal Meibomian gland function
Key exclusion criteria (5 listed)
- 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 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 and paracetamol) 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 since the last dose.
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 |
|---|---|---|
| F901318Administration of active compound | Drug | A active, B active, C active, D1 active, D2 active, E1 active, E2 active, F1 active, F2 active |
| PlaceboAdministration of placebo | Drug | A placebo, B placebo, C placebo, D1 placebo, D2 placebo, E1 placebo, E2 placebo, F1 placebo, F2 placebo |
Primary outcome
safety: adverse events
Time frame: 13 days
adverse events
2 secondary outcomes
pharmacokinetics AUC
Time frame: 13 days
pharmacokinetics Cmin
Time frame: 13 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
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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.
Frans van den Berg, MB ChB principal investigator
Hammersmith Medicines 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 4 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 19 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
safety: adverse events (time frame: 13 days). 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 19 Sep 2016.