AsthmaPhase 1NCT04576325
Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma
A Phase 1 study testing Voriconazole Inhalation Powder in people with Asthma, run by TFF Pharmaceuticals, Inc. at 1 site in Australia.
Trial summary
This is a Phase 1b, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetic profiles of voriconazole inhalation powder in adult subjects with well-controlled asthma. This study will involve 2 cohorts. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- Voriconazole Inhalation Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Nov 2020to 12 Nov 2021
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Provide written informed consent to participate and is willing and able to participate in the study and abide by study restrictions in the judgement of the Investigator.
- Males or non-pregnant, non-lactating females.
- Well-controlled Step 2 or Step 3 asthma defined by the GINA guidelines.
- Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening.
- Normal blood pressure at Screening and Check-In.
- Normal clinical laboratory tests at Screening and Check-In.
- Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody, human immunodeficiency virus (HIV) I and II antibodies, tuberculosis (TB), or COVID-19 at Screening.
- Able to successfully perform spirometry and use the inhalation device, as demonstrated at Screening and Check-In.
Who cannot join
- History or presence of clinically significant medical, ophthalmic, or psychiatric conditions or diseases in the opinion of the Investigator or designee.
- History or current evidence of any chronic upper or lower respiratory conditions other than asthma or allergic (seasonal or perennial), or non-allergic rhinitis. History of mild acute upper or lower respiratory conditions are allowed, provided that it has been at least 3 months since the condition resolved and provided that in the Investigator's judgement, this occurrence poses no additional risk for this subject.
- History of any illness or surgery within 6 months of Screening that, in the opinion of the Investigator, might confound the results of the study or that poses an additional risk to the subject by their participation in the study.
- Current or former smokers, users of e-cigarettes or nicotine replacement products who have more than a 10-pack year history of smoking and who have used these products within the 6 months prior to Screening.
- History or presence of alcoholism or drug abuse within the past 2 years prior to Screening.
- History or presence of hypersensitivity or idiosyncratic reaction to voriconazole or any triazole antifungal.
Show all 15Show fewer
- Received any marketed or investigational biologic within 4 months or 5 half-lives prior to dosing, whichever is longer.
- Received treatment with investigational study drug (or device) in another clinical study within 30 days or five half-lives of dosing, whichever is longer.
- Subjects who have taken any of the protocol prohibited medications within 30 days of the first dose or who are expected to require these medications during the study.
- ECG with a QTcF interval >450 msec for males or QTcF interval > 470 msec for females or ECG findings deemed clinically significantly abnormal by the Investigator prior to the first dose.
- Unable to refrain from or anticipates the use of any vitamin supplements, prescription, over-the-counter (OTC), herbal preparations or medications other than those specified for asthma or allergic rhinitis medications, or topical ophthalmic drops beginning 14 days prior to the first dose and throughout the study.
- Females requiring hormone replacement therapy within 30 days of Screening or during the study.
- Allergy or sensitivity to lactose or milk products.
- Donation of blood or blood products within the last 2 months.
- Loss of 50 to 500 mL whole blood within the past two months.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Q-Pharm Pty Ltd (Nucleus Networks)
Brisbane, Queensland, 4006
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma
This is a Phase 1b, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetic profiles of voriconazole inhalation powder in adult subjects with well-controlled asthma. This study will involve 2 cohorts.
Read the detailed description
This is a Phase 1b, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of voriconazole inhalation powder (VIP) in adult subjects with well-controlled Step 2 or Step 3 asthma. This study will involve a minimum of 2 cohorts. The first 2 subjects randomized into each cohort will be sentinel subjects (i.e., one assigned to VIP and one assigned to placebo). If study drug is deemed safe by the PI, the remaining 6 subjects (5 on VIP and 1 on placebo) may be enrolled.
- In Cohort 1, 8 eligible subjects will be randomized in a 3:1 ratio (6 on active and 2 on placebo) to receive 7 doses BID (over 3.5 days) of 40mg VIP or inhaled placebo. Following completion of Cohort 1 and after dose escalation has been approved by the SMC, Cohort 2 may begin.
- In Cohort 2, 8 eligible subjects will be randomized in a 3:1 ratio to receive 7 doses BID (over 3.5 days) of 80 mg VIP or placebo . Doses will be administered twice daily every 12 (± 1 hours).
A third cohort with the same design and number of subjects may be initiated if there are safety or other findings from Cohort 2 that warrant investigation of an intermediary dose (e.g., VIP 60 mg BID). The decision to initiate this potential 3rd cohort will be made by the Sponsor in collaboration with the safety monitoring committee (SMC). A sentinel design will not be required for this cohort.
Following a variable length Screening period, all subjects will be domiciled in a clinical research facility from the Check-In Day (Day -1) and will remain domiciled until the morning of Day 5. A follow-up phone call or clinic visit (depending on best practices at the time for Coronavirus Disease 2019 [COVID-19] precautions) will be made one week later to assess subject status and record any adverse events (AEs).
Safety will be assessed by monitoring AEs, clinical laboratory tests, vital signs, pulse oximetry, spirometry, 12-lead ECGs, and physical examinations. Blood PK will be assessed from serial blood collections following Dose 1 and Dose 7. Study treatment stopping rules for individual subjects will be based on AEs, SAEs, required changes during the treatment period to asthma medications, spirometry measure of forced expiratory volume at 1 second (FEV1), and increases in QTcF values on ECG.
The SMC will review the safety information accrued during the study and will be responsible for reviewing Cohort 1 safety information before authorizing dose escalation to Cohort 2.
- Conditions
- Asthma
- Being tested
- Voriconazole Inhalation Powder, Placebo
- Keywords
- voriconazole, asthmatic, inhaled, VFEND, aspergillosis, IPA, fungal infection, pulmonary aspergillosis
- Medical subject headings
- Asthma, Respiratory Aspiration, Aspergillosis, Mycoses, Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voriconazole Inhalation PowderDrug
Also called VIP
For each dose, multiple inhalations will be required (4 capsules in Cohort 1 and 8 capsules in Cohort 2). All capsules for a given dose must be inhaled over a maximum 10-minute period. Cohort 1 will receive 40 mg BID and Cohort 2 will receive 80 mg BID. Both Cohorts will administer study drug for 3.5 days (7 days total).
PlaceboDrug
Also called Vehicle
For each dose, multiple inhalations will be required (4 capsules in Cohort 1 and 8 capsules in Cohort 2). All capsules must be inhaled over a maximum 10-minute period. Cohort 1 will receive 4 capsules of inactive BID and Cohort 2 will receive 8 capsules of inactive BID. Both Cohorts will administer placebo capsules for 3.5 days (7 days total).
| Study group | Role | What they receive |
|---|---|---|
| Voriconazole Inhalation Powder | Experimental | Investigational drug will be supplied as capsules, each capsule contains 10 mg of Voriconazole Inhalation Powder. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device. Receives: Drug: Voriconazole Inhalation Powder |
| Placebo | Placebo comparator | Placebo will be supplied as capsules, each capsule will contain no active ingredient. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience Adverse Events (AEs), Serious Adverse Events (SAEs) and withdrawals due to AEs
Frequency of AEs, SAEs, and discontinuations due to AEs
Measured: Through study completion, an average of 14 days
Number of participants who experience vital sign abnormalities
Number of participants with potentially clinically significant vital sign values
Measured: Baseline through study completion, an average of 14 days
Number of participants who experience pulse oximetry abnormalities
Number of participants with potentially clinically significant pulse oximetry values
Measured: Baseline through study completion, an average of 14 days
Mean change from baseline in forced expiratory volume (FEV1)
Spirometry used to measure FEV1 lung function
Measured: Baseline through study completion, an average of 14 days
Mean change from baseline in forced vital capacity (FVC)
Spirometry used to measure FVC lung function
Measured: Baseline through study completion, an average of 14 days
Mean change from baseline in forced expiratory flow over the middle 1/2 of the FVC (FEF25-75%)
Spirometry used to measure FVC and FEF25-75% lung function
Measured: Baseline through study completion, an average of 14 days
Mean change from baseline in FEV1/FVC ratio
Spirometry used to measure FEV1 and FVC lung function
Measured: Baseline through study completion, an average of 14 days
Mean change from baseline in QTcF changes via ECG
Number of participants with potentially clinically significant ECG values
Measured: Baseline through study completion, an average of 14 days
Number of participants who experience physical examination abnormalities
Number of participants with potentially clinically significant physical examination findings
Measured: Baseline through study completion, an average of 14 days
Number of participants who experience laboratory test abnormalities
Number of participants with potentially clinically significant laboratory test results
Measured: Baseline through study completion, an average of 14 days
Secondary outcomes (9)
PK of VIP in plasma: Area under the plasma-concentration time curve (AUC)
Blood samples will be collected for plasma analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Area under the plasma-concentration time curve over the first 12 hours after dosing (AUC0-12)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-tlast)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Area under the concentration time curve from time 0 extrapolated to infinity (AUC∞)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Maximum observed concentration (Cmax)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Time to maximal observed concentration (tmax)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Termination elimination half-life (t½)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Apparent total body clearance (CL/F)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Apparent volume of distribution during the terminal elimination phase (Vz/F)
Blood samples will be collected for analysis
Measured: Predose Day 1 and through 12 hours post last dose (day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start15 Nov 2020
- Primary completion12 Nov 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In each cohort, 8 eligible subjects will be randomized in a 3:1 ratio (6 on active and 2 on placebo) to receive 7 doses (over 3.5 days) of VIP BID or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- TFF Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dale Christensen, PhD, Study director, TFF Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576325
- Sponsor's protocol ID
- TFF-V1-002
- Status last verified
- Nov 2021
- First submitted
- 25 Sep 2020
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma
- ClinicalTrials.gov ID
- NCT04576325
- Acronym / sponsor ID
- TFF-V1-002
- Conditions
- Asthma
- Keywords
- voriconazole, asthmatic, inhaled, VFEND, aspergillosis, IPA, fungal infection, pulmonary aspergillosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- TFF Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 6 Oct 2020 (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.
This is a Phase 1b, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetic profiles of voriconazole inhalation powder in adult subjects with well-controlled asthma. This study will involve 2 cohorts.
Detailed description
This is a Phase 1b, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of voriconazole inhalation powder (VIP) in adult subjects with well-controlled Step 2 or Step 3 asthma. This study will involve a minimum of 2 cohorts. The first 2 subjects randomized into each cohort will be sentinel subjects (i.e., one assigned to VIP and one assigned to placebo). If study drug is deemed safe by the PI, the remaining 6 subjects (5 on VIP and 1 on placebo) may be enrolled.
- In Cohort 1, 8 eligible subjects will be randomized in a 3:1 ratio (6 on active and 2 on placebo) to receive 7 doses BID (over 3.5 days) of 40mg VIP or inhaled placebo. Following completion of Cohort 1 and after dose escalation has been approved by the SMC, Cohort 2 may begin.
- In Cohort 2, 8 eligible subjects will be randomized in a 3:1 ratio to receive 7 doses BID (over 3.5 days) of 80 mg VIP or placebo . Doses will be administered twice daily every 12 (± 1 hours).
A third cohort with the same design and number of subjects may be initiated if there are safety or other findings from Cohort 2 that warrant investigation of an intermediary dose (e.g., VIP 60 mg BID). The decision to initiate this potential 3rd cohort will be made by the Sponsor in collaboration with the safety monitoring committee (SMC). A sentinel design will not be required for this cohort.
Following a variable length Screening period, all subjects will be domiciled in a clinical research facility from the Check-In Day (Day -1) and will remain domiciled until the morning of Day 5. A follow-up phone call or clinic visit (depending on best practices at the time for Coronavirus Disease 2019 [COVID-19] precautions) will be made one week later to assess subject status and record any adverse events (AEs).
Safety will be assessed by monitoring AEs, clinical laboratory tests, vital signs, pulse oximetry, spirometry, 12-lead ECGs, and physical examinations. Blood PK will be assessed from serial blood collections following Dose 1 and Dose 7. Study treatment stopping rules for individual subjects will be based on AEs, SAEs, required changes during the treatment period to asthma medications, spirometry measure of forced expiratory volume at 1 second (FEV1), and increases in QTcF values on ECG.
The SMC will review the safety information accrued during the study and will be responsible for reviewing Cohort 1 safety information before authorizing dose escalation to Cohort 2.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- In each cohort, 8 eligible subjects will be randomized in a 3:1 ratio (6 on active and 2 on placebo) to receive 7 doses (over 3.5 days) of VIP BID or placebo
| Arm | Type | Receives |
|---|---|---|
| Voriconazole Inhalation Powder | Experimental | Drug: Voriconazole Inhalation PowderInvestigational drug will be supplied as capsules, each capsule contains 10 mg of Voriconazole Inhalation Powder. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be supplied as capsules, each capsule will contain no active ingredient. The capsules will be administered with the provided breath actuated Plastiape RS00 Model 8 Dry Powder Inhaler device. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Provide written informed consent to participate and is willing and able to participate in the study and abide by study restrictions in the judgement of the Investigator.
- Males or non-pregnant, non-lactating females.
- Well-controlled Step 2 or Step 3 asthma defined by the GINA guidelines.
- Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening.
- Normal blood pressure at Screening and Check-In.
Key exclusion criteria (15 listed)
- History or presence of clinically significant medical, ophthalmic, or psychiatric conditions or diseases in the opinion of the Investigator or designee.
- History or current evidence of any chronic upper or lower respiratory conditions other than asthma or allergic (seasonal or perennial), or non-allergic rhinitis. History of mild acute upper or lower respiratory conditions are allowed, provided that it has been at least 3 months since the condition resolved and provided that in the Investigator's judgement, this occurrence poses no additional risk for this subject.
- History of any illness or surgery within 6 months of Screening that, in the opinion of the Investigator, might confound the results of the study or that poses an additional risk to the subject by their participation in the study.
- Current or former smokers, users of e-cigarettes or nicotine replacement products who have more than a 10-pack year history of smoking and who have used these products within the 6 months prior to Screening.
- History or presence of alcoholism or drug abuse within the past 2 years prior to Screening.
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 |
|---|---|---|
| Voriconazole Inhalation PowderAlso: VIPFor each dose, multiple inhalations will be required (4 capsules in Cohort 1 and 8 capsules in Cohort 2). All capsules for a given dose must be inhaled over a maximum 10-minute period. Cohort 1 will receive 40 mg BID and Cohort 2 will receive 80 mg BID. Both Cohorts will administer study drug for 3.5 days (7 days total). | Drug | Voriconazole Inhalation Powder |
| PlaceboAlso: VehicleFor each dose, multiple inhalations will be required (4 capsules in Cohort 1 and 8 capsules in Cohort 2). All capsules must be inhaled over a maximum 10-minute period. Cohort 1 will receive 4 capsules of inactive BID and Cohort 2 will receive 8 capsules of inactive BID. Both Cohorts will administer placebo capsules for 3.5 days (7 days total). | Drug | Placebo |
Primary outcome
Number of participants who experience Adverse Events (AEs), Serious Adverse Events (SAEs) and withdrawals due to AEs
Time frame: Through study completion, an average of 14 days
Frequency of AEs, SAEs, and discontinuations due to AEs
Number of participants who experience vital sign abnormalities
Time frame: Baseline through study completion, an average of 14 days
Number of participants with potentially clinically significant vital sign values
Number of participants who experience pulse oximetry abnormalities
Time frame: Baseline through study completion, an average of 14 days
Number of participants with potentially clinically significant pulse oximetry values
Mean change from baseline in forced expiratory volume (FEV1)
Time frame: Baseline through study completion, an average of 14 days
Spirometry used to measure FEV1 lung function
Mean change from baseline in forced vital capacity (FVC)
Time frame: Baseline through study completion, an average of 14 days
Spirometry used to measure FVC lung function
Mean change from baseline in forced expiratory flow over the middle 1/2 of the FVC (FEF25-75%)
Time frame: Baseline through study completion, an average of 14 days
Spirometry used to measure FVC and FEF25-75% lung function
Mean change from baseline in FEV1/FVC ratio
Time frame: Baseline through study completion, an average of 14 days
Spirometry used to measure FEV1 and FVC lung function
Mean change from baseline in QTcF changes via ECG
Time frame: Baseline through study completion, an average of 14 days
Number of participants with potentially clinically significant ECG values
Number of participants who experience physical examination abnormalities
Time frame: Baseline through study completion, an average of 14 days
Number of participants with potentially clinically significant physical examination findings
Number of participants who experience laboratory test abnormalities
Time frame: Baseline through study completion, an average of 14 days
Number of participants with potentially clinically significant laboratory test results
9 secondary outcomes
PK of VIP in plasma: Area under the plasma-concentration time curve (AUC)
Time frame: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Area under the plasma-concentration time curve over the first 12 hours after dosing (AUC0-12)
Time frame: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-tlast)
Time frame: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Area under the concentration time curve from time 0 extrapolated to infinity (AUC∞)
Time frame: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Maximum observed concentration (Cmax)
Time frame: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Time to maximal observed concentration (tmax)
Time frame: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Termination elimination half-life (t½)
Time frame: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Apparent total body clearance (CL/F)
Time frame: Predose Day 1 and through 12 hours post last dose (day 4)
PK of VIP in plasma: Apparent volume of distribution during the terminal elimination phase (Vz/F)
Time frame: Predose Day 1 and through 12 hours post last dose (day 4)
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 18 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Dale Christensen, PhD study director
TFF Pharmaceuticals
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 Voriconazole Inhalation Powder in people with Asthma, run by TFF Pharmaceuticals, Inc. at 1 site in Australia.
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 8 inclusion and 15 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 18 Nov 2021. 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 Australia. 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?
Number of participants who experience Adverse Events (AEs), Serious Adverse Events (SAEs) and withdrawals due to AEs (time frame: Through study completion, an average of 14 days). The study lists 10 primary outcomes in all. 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 18 Nov 2021.