Healthy VolunteersPhase 1NCT04892641
Phase 1 Study of Epetraborole Tablets
A Phase 1 study testing Epetraborole in people with Healthy Volunteers, run by AN2 Therapeutics, Inc at 1 site in Australia.
Trial summary
This is a Phase 1b double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and food effect of epetraborole tablets administered to healthy adult subjects for up to 28 days. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Epetraborole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Jun 2021to 26 Feb 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who meet all the following criteria will be considered for inclusion in the study:
- Healthy adult males and/or females of 18 to 65 years of age (inclusive) at the time of Screening.
- Willing and able to provide written informed consent.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 and weight between 40.0 kg and 100.0 kg (inclusive) at Screening.
- Medically healthy without CS abnormalities at the Screening Visit or Day -1, including:
- Physical examination, vital signs including temperature, HR, respiratory rate, and blood pressure
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- Triplicate ECGs taken at least 1 minute apart with QTcF interval duration ≤ 450 msec obtained as an average from the triplicate Screening and pre-dose Day 1 ECGs after at least 5 minutes in a semi-supine, quiet rest position
- Hematological parameters (including hemoglobin, hematocrit, red blood cells [RBC], packed cell volume [PCV], mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], red cell distribution width [RDW], platelet count, white blood cell [WBC] and differential, and reticulocytes) are equal to or greater than the lower limit of normal (LLN) of the normal range of the reference laboratory
- Estimated creatinine clearance (CrCl) or glomerular filtration rate (GFR) < 80 mL/min using Cockcroft-Gault formula (calculated creatinine clearance or GFR = [{140-Age} × Weight {in kg}] \ [72 × Serum creatinine {in mg/dL}] × 0.85 [if female]); ALT and AST equal to or ≤ 1.5 times the ULN; results of all other clinical chemistry and urine analytes without any CS abnormality Note: Discussion between the PI and the Sponsor Medical Monitor (MM) is required regarding any potentially CS abnormal laboratory value during the pre-dose period.
- Non-smoker (including tobacco, e-cigarettes, nicotine patches or marijuana) for at least 1 month prior to randomization, which will be confirmed by urine cotinine test at Screening and on Day -1 (admission).
- Willing and able to comply with all study assessments and adhere to the protocol schedule, including the entire confinement period and the F/U visits.
- Have suitable venous access for blood sampling.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and on Day -1 (admission) and be willing to have additional pregnancy tests, as required, throughout the study.
- WOCBP must agree to and comply with using 1 barrier method (e.g., female condom or male partner using a condom) plus 1 other highly effective method of birth control (e.g., oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones, intrauterine device [IUD], vasectomized partner), or sexual abstinence, for the duration of the study (from signing of consent to final F/U visit) and for 30 days after last IP administration.
- WOCBP must also agree not to donate ova or oocytes (i.e., human eggs) during the study, and for one menstrual cycle after completion of the study To be considered of non-childbearing potential, a female must have either a tubal ligation, hysterectomy, bilateral salpingo-oophrectomy, or menopause (last menstruation > 12 months and follicle-stimulating hormone [FSH] levels ≥ 40 IU/mL at Screening); provision of written documentation is not required for female sterilization and oral confirmation is adequate.
- Female subjects who are in same-sex relationships are not required to use contraception.
- Males must be surgically sterile (> 30 days since vasectomy), abstinent, or if engaged in sexual relations with a WOCBP, the subject and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from Screening until study completion, including the F/U period. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner that includes: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring or an IUD. Subjects with same-sex partners are eligible when this is their preferred and usual lifestyle.
- Males must not donate sperm for the duration of the study (from signing of consent to final F/U visit) and for 90 days after last IP administration.
- Subjects must agree to adhere to the current state and national advice regarding minimizing exposure to coronavirus disease of 2019 (COVID-19) from the first Screening Visit until the final F/U visit.
Who cannot join
- Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the F/U period.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be CS.
- Iron, B12 or folate outside of the normal range at Screening and any history of anemia (e.g. iron deficiency, B12 or folate deficiency, or hemoglobinopathy).
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years prior to Screening.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome).
- Has/had febrile illness or symptomatic viral, bacterial (including upper respiratory tract infection) or fungal infection within 2 weeks prior to randomization.
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- Unable to swallow solid, oral dosage forms whole with the aid of water.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
- Positive urine drug screen or alcohol breath test at Screening or Day -1, or history of substance abuse or alcohol abuse (defined as greater than 2 standard drinks on average each and every day, where 1 standard drink is defined as containing 10 g of alcohol and is equivalent to 1 can or stubby of mid-strength beer, 30 mL nip of spirits, or 100 mL of wine) within the previous 6 months.
- Use of any prescription medication or any over the counter (OTC) medication, including erythropoietin stimulating agents, herbal products and vitamins, within 7 days prior to randomization.
- Note: An exception is made for hormonal contraceptives and intermittent, as-needed acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) for the treatment of transient headache or any other minor ache/pain. Discussion between the PI and the Sponsor MM is encouraged regarding the acceptability of the prior use of any medications during the pre-dose period.
- Any vaccinations or planned vaccinations (including COVID-19 and influenza) within 14 days prior to dosing on Day 1 and for the duration of the study (up to the F/U visit).
- Documented significant hypersensitivity reaction or anaphylaxis to any medication, which in the opinion of the Investigator could compromise subject safety.
- Donation of blood or plasma within 30 days prior to randomization, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or past receipt of a blood transfusion at any time.
- Received an investigational intervention (including an investigational vaccine) or used an invasive investigational medical device within 30 days (or 5 half-lives whichever is longer) prior to Day 1.
- Any other condition or prior therapy, which, in the opinion of the PI, would make the volunteer unsuitable for this study, including unable to cooperate fully with the requirements of the study protocol or likely to be non-compliant with any study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Placebo-controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of Epetraborole Tablets Administered for up to 28 Days in Healthy Adult Subjects
This is a Phase 1b double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and food effect of epetraborole tablets administered to healthy adult subjects for up to 28 days.
Read the detailed description
Up to 56 healthy male and female adult subjects will be enrolled into one of 7 Dose Cohorts (Dose Cohorts 1 to 7; n = 8 per cohort). Cohort 7 (n = 8) is a Food Effect Cohort and subjects will receive a single dose of epetraborole or placebo in a Fasted state (Period 1) followed by a second dose of the same Investigational Product (IP) in a Fed state (Period 2) after a washout period of at least 7 days (+3 days). The dose of IP to be administered in Cohort 7 will be determined based on the Safety Monitoring Group recommendation following evaluation of safety and available PK data (at least 14 days) in Cohort 1 through Cohort 6. Up to 16 additional subjects may be included for the purposes of cohort expansion or to explore a dose intermediate to previously evaluated doses.
Subjects in each Dose Cohort (n=8) will be randomized 3:1 to receive epetraborole (n=6) or matching placebo (n=2) and will receive oral doses of epetraborole or placebo. Investigational product will be administered with approximately 240 mL (8 fluid ounces) of non-carbonated water to each subject following an overnight fast of at least 8 hours, except for Period 2 (Fed) of Cohort 7. Subjects will be required to fast for a minimum of 2 hours following administration of IP.
- Conditions
- Healthy Volunteers
- Being tested
- Epetraborole, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpetraboroleDrug
Also called AN2-501971
Epetraborole hydrochloride 250 mg tablets for oral administration
PlaceboDrug
Matching placebo for 250 mg epetraborole hydrochloride tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Epetraborole for Dose Ranging | Experimental | Epetraborole hydrochloride 250 mg, 500 mg, 750 mg, or 1000 mg PO q24h or 500 mg or 1000 mg PO q48h Receives: Drug: Epetraborole |
| Placebo for Dose Ranging | Placebo comparator | Matching placebo for dose ranging Receives: Drug: Placebo |
| Epetraborole for Food Effect | Experimental | Food effect cohort, single dose in fed and fasted conditions, dosage to be determined based on pharmacokinetics data obtained from previous cohorts Receives: Drug: Epetraborole |
| Placebo for Food Effect | Placebo comparator | Food effect cohort, single dose in fed and fasted conditions, dosage to be determined based on pharmacokinetics data obtained from previous cohorts Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion
Incidence, relatedness, and severity of adverse events
Measured: From Day 1 through last follow-up visit (7 days after last dose)
Evaluate Physical Examination Abnormalities from Baseline Through Study Completion
Incidence of physical exam abnormalities
Measured: From Day 1 through last follow-up visit (7 days after last dose)
Evaluate Change in Vital Signs from Baseline Through Study Completion
Incidence of changes in blood pressure, pulse, respiratory rate, and temperature
Measured: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion
Incidence of changes in 12-lead ECG parameters from baseline
Measured: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion
Incidence of changes in clinical laboratory measurements from baseline
Measured: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Characterize the PK Profile of Epetraborole: Maximum Plasma Concentration
Determination of the maximum plasma concentration (Cmax)
Measured: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Characterize the PK Profile of Epetraborole: Minimum Steady State Plasma Concentration During a Dosage Interval
Determination of the minimum steady state plasma drug concentration during a dosage interval (Cmin)
Measured: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Characterize the PK Profile of Epetraborole: Time to Maximum Plasma Concentration
Determination the time to maximum plasma concentration (Tmax)
Measured: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Characterize the PK Profile of Epetraborole: Area Under the Plasma Concentration Versus Time Curve from Time 0 to the Last Time Point Evaluated
Determine the area under the plasma concentration versus time curve from time 0 to the last time point evaluated (AUC0-t) with the plasma concentration at time "t" being the last measurable concentration
Measured: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Characterize the PK Profile of Epetraborole: Area Under the Plasma Concentration Versus Time Curve from Time 0 to Infinity
Determine area under the drug concentration versus time curve, from time zero to infinity (AUC0-inf)
Measured: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Characterize the PK Profile of Epetraborole: Last Quantifiable Concentration
Determine the actual time of last quantifiable concentration used in the determination of AUC0-last (Tlast)
Measured: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Characterize the PK Profile of Epetraborole: Terminal Half-Life
Determine the apparent terminal half-life (t½)
Measured: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Characterize the PK Profile of Epetraborole: Terminal Elimination Rate Constant
Determine apparent terminal elimination rate constant (Kel)
Measured: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start10 Jun 2021
- Primary completion26 Feb 2022
- Study completion26 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- AN2 Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angela Molga, M.D., Principal investigator, CMAX Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892641
- Sponsor's protocol ID
- EBO-101
- Status last verified
- Mar 2024
- First submitted
- 11 May 2021
- Last updated
- 21 Mar 2024
- Results posted
- 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 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Placebo-controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of Epetraborole Tablets Administered for up to 28 Days in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04892641
- Acronym / sponsor ID
- EBO-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- AN2 Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 26 Feb 2022 (actual)
- Study completion
- 26 Feb 2022 (actual)
- First posted
- 19 May 2021 (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 double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and food effect of epetraborole tablets administered to healthy adult subjects for up to 28 days.
Detailed description
Up to 56 healthy male and female adult subjects will be enrolled into one of 7 Dose Cohorts (Dose Cohorts 1 to 7; n = 8 per cohort). Cohort 7 (n = 8) is a Food Effect Cohort and subjects will receive a single dose of epetraborole or placebo in a Fasted state (Period 1) followed by a second dose of the same Investigational Product (IP) in a Fed state (Period 2) after a washout period of at least 7 days (+3 days). The dose of IP to be administered in Cohort 7 will be determined based on the Safety Monitoring Group recommendation following evaluation of safety and available PK data (at least 14 days) in Cohort 1 through Cohort 6. Up to 16 additional subjects may be included for the purposes of cohort expansion or to explore a dose intermediate to previously evaluated doses.
Subjects in each Dose Cohort (n=8) will be randomized 3:1 to receive epetraborole (n=6) or matching placebo (n=2) and will receive oral doses of epetraborole or placebo. Investigational product will be administered with approximately 240 mL (8 fluid ounces) of non-carbonated water to each subject following an overnight fast of at least 8 hours, except for Period 2 (Fed) of Cohort 7. Subjects will be required to fast for a minimum of 2 hours following administration of IP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Epetraborole for Dose Ranging | Experimental | Drug: EpetraboroleEpetraborole hydrochloride 250 mg, 500 mg, 750 mg, or 1000 mg PO q24h or 500 mg or 1000 mg PO q48h |
| Placebo for Dose Ranging | Placebo comparator | Drug: PlaceboMatching placebo for dose ranging |
| Epetraborole for Food Effect | Experimental | Drug: EpetraboroleFood effect cohort, single dose in fed and fasted conditions, dosage to be determined based on pharmacokinetics data obtained from previous cohorts |
| Placebo for Food Effect | Placebo comparator | Drug: PlaceboFood effect cohort, single dose in fed and fasted conditions, dosage to be determined based on pharmacokinetics data obtained from previous cohorts |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects who meet all the following criteria will be considered for inclusion in the study:
- Healthy adult males and/or females of 18 to 65 years of age (inclusive) at the time of Screening.
- Willing and able to provide written informed consent.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 and weight between 40.0 kg and 100.0 kg (inclusive) at Screening.
- Medically healthy without CS abnormalities at the Screening Visit or Day -1, including:
Key exclusion criteria (16 listed)
- Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the F/U period.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be CS.
- Iron, B12 or folate outside of the normal range at Screening and any history of anemia (e.g. iron deficiency, B12 or folate deficiency, or hemoglobinopathy).
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years prior to Screening.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome).
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 |
|---|---|---|
| EpetraboroleAlso: AN2-501971Epetraborole hydrochloride 250 mg tablets for oral administration | Drug | Epetraborole for Dose Ranging, Epetraborole for Food Effect |
| PlaceboMatching placebo for 250 mg epetraborole hydrochloride tablets for oral administration | Drug | Placebo for Dose Ranging, Placebo for Food Effect |
Primary outcome
Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion
Time frame: From Day 1 through last follow-up visit (7 days after last dose)
Incidence, relatedness, and severity of adverse events
Evaluate Physical Examination Abnormalities from Baseline Through Study Completion
Time frame: From Day 1 through last follow-up visit (7 days after last dose)
Incidence of physical exam abnormalities
Evaluate Change in Vital Signs from Baseline Through Study Completion
Time frame: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Incidence of changes in blood pressure, pulse, respiratory rate, and temperature
Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion
Time frame: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Incidence of changes in 12-lead ECG parameters from baseline
Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion
Time frame: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Incidence of changes in clinical laboratory measurements from baseline
Characterize the PK Profile of Epetraborole: Maximum Plasma Concentration
Time frame: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Determination of the maximum plasma concentration (Cmax)
Characterize the PK Profile of Epetraborole: Minimum Steady State Plasma Concentration During a Dosage Interval
Time frame: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Determination of the minimum steady state plasma drug concentration during a dosage interval (Cmin)
Characterize the PK Profile of Epetraborole: Time to Maximum Plasma Concentration
Time frame: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Determination the time to maximum plasma concentration (Tmax)
Characterize the PK Profile of Epetraborole: Area Under the Plasma Concentration Versus Time Curve from Time 0 to the Last Time Point Evaluated
Time frame: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Determine the area under the plasma concentration versus time curve from time 0 to the last time point evaluated (AUC0-t) with the plasma concentration at time "t" being the last measurable concentration
Characterize the PK Profile of Epetraborole: Area Under the Plasma Concentration Versus Time Curve from Time 0 to Infinity
Time frame: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Determine area under the drug concentration versus time curve, from time zero to infinity (AUC0-inf)
Characterize the PK Profile of Epetraborole: Last Quantifiable Concentration
Time frame: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Determine the actual time of last quantifiable concentration used in the determination of AUC0-last (Tlast)
Characterize the PK Profile of Epetraborole: Terminal Half-Life
Time frame: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Determine the apparent terminal half-life (t½)
Characterize the PK Profile of Epetraborole: Terminal Elimination Rate Constant
Time frame: From Day 1 to follow-up visit through last follow-up visit (7 days after last dose)
Determine apparent terminal elimination rate constant (Kel)
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 21 Mar 2024.
- 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.
Angela Molga, M.D. principal investigator
CMAX Clinical 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 Epetraborole in people with Healthy Volunteers, run by AN2 Therapeutics, 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 19 inclusion and 16 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 21 Mar 2024. 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?
Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion (time frame: From Day 1 through last follow-up visit (7 days after last dose)). The study lists 13 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 21 Mar 2024.