Invasive AspergillosisPhase 1NCT03076905
Pharmacokinetics of IV Formulation
A Phase 1 study testing F901318 in people with Invasive Aspergillosis, run by F2G Ltd.
Trial summary
Open label evaluation of a single intravenous dose of F901318 to healthy male and female subjects with pharmacokinetic and safety and tolerability evaluation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy 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?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2017to Aug 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be males or females of any ethnic origin between 18 and 55 years or age and weighing between 50 and 100kg.
- Females of child bearing potential must be established on a reliable form of contraception and have a negative pregnancy test at screening and Day -1
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (hepatic transaminases must be within normal limits, 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
- Female and male subjects who are not, or whose partners are not willing to use appropriate contraception with two reliable forms of contraception or who are not otherwise unable to conceive children (hysterectomy, oophorectomy, tubal ligation or post menopausal).
- Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration 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 the dose administration (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
About this study
Official title: F901318 - A Phase I, Single Intravenous Dose, Safety, Tolerability and Pharmacokinetics Study in Healthy Male and Female Subjects
Open label evaluation of a single intravenous dose of F901318 to healthy male and female subjects with pharmacokinetic and safety and tolerability evaluation.
Read the detailed description
Open label single intravenous dose, single group study. Eight subjects (ideally 4 male and 4 female, minimum of two females) will be studied. The drug product will be a F901318 solution for infusion (6mg/mL). The dose will be 4 mg/kg delivered in the fasted state (8 hours minimum) by intravenous infusion over 2 hours. Each subject will be on study for approximately 6 weeks. Each subject will reside at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 4 (72 hours post-dose). Blood samples for pharmacokinetic evaluation will be obtained up to and including 120 hours post dose. Safety and tolerability will also be assessed.
Subjects will return to the clinical unit at 96 and 120 hours for pharmacokinetic blood sampling.
All subjects will return for a post-study visit 8 to 10 days after the dose of study medication.
- Conditions
- Invasive Aspergillosis
- Being tested
- F901318
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F901318Drug
Evaluation of AUC0-t
| Study group | Role | What they receive |
|---|---|---|
| IV drug | Experimental | AUC0-t of single intravenous dose of F901318 Receives: Drug: F901318 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile (AUC0-t)
AUC0-t
Measured: 120 hours
Secondary outcomes (1)
Tolerability (Adverse events)
Adverse events
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startMay 2017 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: study no longer required in current format
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
- Not applicable
- Intervention model
- Single group
- Model description
- Assessment of IV pharmacokinetics
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- F2G Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Responsible party
- Sponsor
- Investigators
- Litza McKenzie, MD, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076905
- Sponsor's protocol ID
- F901318-01-10-17
- Other IDs
- QCL117986
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F901318 - A Phase I, Single Intravenous Dose, Safety, Tolerability and Pharmacokinetics Study in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03076905
- Acronym / sponsor ID
- F901318-01-10-17
- Conditions
- Invasive Aspergillosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study no longer required in current format
- Enrolment
- 0 participants (actual)
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- May 2017 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 10 Mar 2017 (actual)
- 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.
Open label evaluation of a single intravenous dose of F901318 to healthy male and female subjects with pharmacokinetic and safety and tolerability evaluation.
Detailed description
Open label single intravenous dose, single group study. Eight subjects (ideally 4 male and 4 female, minimum of two females) will be studied. The drug product will be a F901318 solution for infusion (6mg/mL). The dose will be 4 mg/kg delivered in the fasted state (8 hours minimum) by intravenous infusion over 2 hours. Each subject will be on study for approximately 6 weeks. Each subject will reside at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 4 (72 hours post-dose). Blood samples for pharmacokinetic evaluation will be obtained up to and including 120 hours post dose. Safety and tolerability will also be assessed.
Subjects will return to the clinical unit at 96 and 120 hours for pharmacokinetic blood sampling.
All subjects will return for a post-study visit 8 to 10 days after the dose of study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assessment of IV pharmacokinetics
| Arm | Type | Receives |
|---|---|---|
| IV drug | Experimental | Drug: F901318AUC0-t of single intravenous dose of F901318 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects will be males or females of any ethnic origin between 18 and 55 years or age and weighing between 50 and 100kg.
- Females of child bearing potential must be established on a reliable form of contraception and have a negative pregnancy test at screening and Day -1
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (hepatic transaminases must be within normal limits, 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 (3 listed)
- Female and male subjects who are not, or whose partners are not willing to use appropriate contraception with two reliable forms of contraception or who are not otherwise unable to conceive children (hysterectomy, oophorectomy, tubal ligation or post menopausal).
- Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration 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 the dose administration (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
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 |
|---|---|---|
| F901318Evaluation of AUC0-t | Drug | IV drug |
Primary outcome
Pharmacokinetic profile (AUC0-t)
Time frame: 120 hours
AUC0-t
1 secondary outcome
Tolerability (Adverse events)
Time frame: 120 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Individual participant dataSharing planned: No
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Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
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A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA
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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.
Litza McKenzie, MD principal investigator
Quotient Clinical
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.
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 3 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: withdrawn, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetic profile (AUC0-t) (time frame: 120 hours). 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 1 Nov 2017; AzTrials last refreshed its copy on 1 Nov 2026.