Chronic Kidney DiseasePhase 1NCT04734275
Study to Assess Relative Bioavailability and Safety of AZD5718 in Healthy Volunteers
A Phase 1 study testing AZD5718 in people with Chronic Kidney Disease, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This study will be a randomised, open-label, 3-period, 3-treatment, single-dose, crossover study in healthy subjects The study will be performed at a single study centre in the United Kingdom. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- AZD5718
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2021to 25 Mar 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects aged 18 - 55 years inclusive with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at each admission to the unit, must not be lactating and must be of nonchildbearing potential, confirmed at the Screening Visit.
- Male subjects must adhere to the contraception methods as detailed in protocol.
- Have a body mass index between 18.5 and 30 kg/m^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the principal investigator (PI), may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational Medicinal Product (IMP).
- Any clinically significant abnormalities in clinical chemistry, haematology, coagulation, or urinalysis results, at the Screening Visit and/or on admission to the Clinical Unit for Treatment Period 1 as judged by the PI including:
- Alanine aminotransferase > upper limit of normal (ULN)
- Aspartate aminotransferase > ULN
Show all 27Show fewer
- Bilirubin (total) > ULN
- Gamma glutamyl transferase > ULN
- Any clinically significant abnormal findings in vital signs and 12-lead electrocardiogram at the Screening Visit and/or on each admission to the Clinical Unit, as judged by the Principal Investigator (PI).
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody.
- Any positive result on screening for IgM. If positive for IgG, a reverse transcriptase polymerase chain reaction test for severe acute respiratory syndrome coronavirus 2 must be performed on the same day and if positive, the subject is excluded.
- Known or suspected Gilbert's syndrome.
- Known or suspected significant history of drug abuse.
- Has received another new chemical or biological entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study.
- Plasma donation within 1 month of the Screening Visit or any blood donation/loss more than 500 mL during the 3 months prior to the Screening Visit.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5718.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to the Screening Visit.
- Positive screen for drugs of abuse or cotinine at the Screening Visit or on each admission to the Clinical Unit.
- Positive screen for alcohol at the Screening Visit or on each admission to the Clinical Unit.
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
- Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), hormonal replacement therapy, herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI. Excessive intake of alcohol defined as the regular consumption of more than 24 g (3 units) of alcohol per day for men or 12 g (1.5 units) of alcohol per day for women.
- Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as judged by the PI. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day (eg, > 5 cups of coffee) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the Clinical Unit.
- Subjects who have previously received AZD5718.
- Judgement by the PI that the subject should not participate in the study if they have any ongoing or recent (ie, during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Subjects with any special dietary restrictions such as subjects who are lactose intolerant or with food allergies.
- Subjects who cannot eat a standard Food and Drug Administration high-fat breakfast.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-dose, Open-label, Single-centre, Crossover Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD5718 in Fasted and Fed State in Healthy Volunteers
This study will be a randomised, open-label, 3-period, 3-treatment, single-dose, crossover study in healthy subjects The study will be performed at a single study centre in the United Kingdom.
Read the detailed description
The study will comprise:
- A screening period of maximum 28 days;
- 3 treatment periods during which subjects will be resident at the Clinical Unit from the day before dosing with AZD5718 (Day -1) until at least 48 hours after dosing (Day 3), with discharge on the morning of Day 3 of each treatment period; and
- A final visit within 5 to 7 days after the last administration of AZD5718.
Subjects will receive single doses of AZD5718 on 3 occasions, separated by at least 7 days washout, under fasted and fed conditions. Two different formulations (Test Formulation and Reference Formulation) will be given in a randomised order:
- Treatment A (Test Formulation): AZD5718 Dose A, fasted
- Treatment B (Test Formulation): AZD5718 Dose A, fed
- Treatment C (Reference Formulation): AZD5718 Dose A, fasted
- Conditions
- Chronic Kidney Disease
- Being tested
- AZD5718
- Keywords
- AZD5718, Bioavailability, 5-lipoxygenase activating protein (FLAP) inhibitor, Safety and tolerability
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5718Drug
Subjects will receive single doses of AZD5718 on 3 occasions, separated by at least 7 days washout, under fasted and fed conditions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (Test Formulation): AZD5718 Dose A, fasted | Experimental | Subjects will receive single dose of AZD5718 (Dose A), in fasted condition. Receives: Drug: AZD5718 |
| Treatment B (Test Formulation): AZD5718 Dose A, fed | Experimental | Subjects will receive single dose of AZD5718 (Dose A) in fed condition Receives: Drug: AZD5718 |
| Treatment C (Reference Formulation): AZD5718 Dose A, fasted | Active comparator | Subjects will receive single dose of AZD5718 (Dose A) in fasted condition Receives: Drug: AZD5718 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve from zero to infinity (AUCinf) (Treatment A versus Treatment C)
Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using AUCinf will be assessed.
Measured: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast) (Treatment A versus Treatment C)
Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using AUClast will be assessed.
Measured: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Maximum observed plasma (peak) drug concentration (Cmax) (Treatment A versus Treatment C)
Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using Cmax will be assessed.
Measured: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Plasma concentration at 24h post-dose (C24) (Treatment A versus Treatment C)
Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using C24 will be assessed.
Measured: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
AUCinf (Treatment B versus Treatment A)
Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using AUCinf will be assessed.
Measured: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
AUClast (Treatment B versus Treatment A)
Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using AUClast will be assessed.
Measured: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
C24 (Treatment B versus Treatment A)
Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using C24 will be assessed.
Measured: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Cmax (Treatment B versus Treatment A)
Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using Cmax will be assessed.
Measured: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Secondary outcomes (1)
Number of subjects with adverse events (AEs) and serious AEs
Safety and tolerability of single doses of AZD5718 in healthy subjects will be assessed.
Measured: From screening (SAEs only) until Follow-up Visit (5 to 7 days post final dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Feb 2021
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Pablo Forte Soto, Dr, Principal investigator, Parexel Early Phase Clinical Unit London, Level 7, Northwick Park Hospital Watford Road, Harrow Middlesex HA1 3UJ UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734275
- Sponsor's protocol ID
- D7551C00003
- Status last verified
- Mar 2021
- First submitted
- 28 Jan 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-dose, Open-label, Single-centre, Crossover Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD5718 in Fasted and Fed State in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04734275
- Acronym / sponsor ID
- D7551C00003
- Conditions
- Chronic Kidney Disease
- Keywords
- AZD5718, Bioavailability, 5-lipoxygenase activating protein (FLAP) inhibitor, Safety and tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 2 Feb 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 study will be a randomised, open-label, 3-period, 3-treatment, single-dose, crossover study in healthy subjects The study will be performed at a single study centre in the United Kingdom.
Detailed description
The study will comprise:
- A screening period of maximum 28 days;
- 3 treatment periods during which subjects will be resident at the Clinical Unit from the day before dosing with AZD5718 (Day -1) until at least 48 hours after dosing (Day 3), with discharge on the morning of Day 3 of each treatment period; and
- A final visit within 5 to 7 days after the last administration of AZD5718.
Subjects will receive single doses of AZD5718 on 3 occasions, separated by at least 7 days washout, under fasted and fed conditions. Two different formulations (Test Formulation and Reference Formulation) will be given in a randomised order:
- Treatment A (Test Formulation): AZD5718 Dose A, fasted
- Treatment B (Test Formulation): AZD5718 Dose A, fed
- Treatment C (Reference Formulation): AZD5718 Dose A, fasted
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A (Test Formulation): AZD5718 Dose A, fasted | Experimental | Drug: AZD5718Subjects will receive single dose of AZD5718 (Dose A), in fasted condition. |
| Treatment B (Test Formulation): AZD5718 Dose A, fed | Experimental | Drug: AZD5718Subjects will receive single dose of AZD5718 (Dose A) in fed condition |
| Treatment C (Reference Formulation): AZD5718 Dose A, fasted | Active comparator | Drug: AZD5718Subjects will receive single dose of AZD5718 (Dose A) in fasted condition |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and/or female subjects aged 18 - 55 years inclusive with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at each admission to the unit, must not be lactating and must be of nonchildbearing potential, confirmed at the Screening Visit.
- Male subjects must adhere to the contraception methods as detailed in protocol.
- Have a body mass index between 18.5 and 30 kg/m^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Key exclusion criteria (27 listed)
- History of any clinically significant disease or disorder which, in the opinion of the principal investigator (PI), may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational Medicinal Product (IMP).
- Any clinically significant abnormalities in clinical chemistry, haematology, coagulation, or urinalysis results, at the Screening Visit and/or on admission to the Clinical Unit for Treatment Period 1 as judged by the PI including:
- Any clinically significant abnormal findings in vital signs and 12-lead electrocardiogram at the Screening Visit and/or on each admission to the Clinical Unit, as judged by the Principal Investigator (PI).
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 |
|---|---|---|
| AZD5718Subjects will receive single doses of AZD5718 on 3 occasions, separated by at least 7 days washout, under fasted and fed conditions. | Drug | Treatment A (Test Formulation): AZD5718 Dose A, fasted, Treatment B (Test Formulation): AZD5718 Dose A, fed, Treatment C (Reference Formulation): AZD5718 Dose A, fasted |
Primary outcome
Area under plasma concentration-time curve from zero to infinity (AUCinf) (Treatment A versus Treatment C)
Time frame: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using AUCinf will be assessed.
Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast) (Treatment A versus Treatment C)
Time frame: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using AUClast will be assessed.
Maximum observed plasma (peak) drug concentration (Cmax) (Treatment A versus Treatment C)
Time frame: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using Cmax will be assessed.
Plasma concentration at 24h post-dose (C24) (Treatment A versus Treatment C)
Time frame: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using C24 will be assessed.
AUCinf (Treatment B versus Treatment A)
Time frame: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using AUCinf will be assessed.
AUClast (Treatment B versus Treatment A)
Time frame: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using AUClast will be assessed.
C24 (Treatment B versus Treatment A)
Time frame: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using C24 will be assessed.
Cmax (Treatment B versus Treatment A)
Time frame: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)
Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using Cmax will be assessed.
1 secondary outcome
Number of subjects with adverse events (AEs) and serious AEs
Time frame: From screening (SAEs only) until Follow-up Visit (5 to 7 days post final dose)
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 6 Dec 2021.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Pablo Forte Soto, Dr principal investigator
Parexel Early Phase Clinical Unit London, Level 7, Northwick Park Hospital Watford Road, Harrow Middlesex HA1 3UJ UK
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 AZD5718 in people with Chronic Kidney Disease, run by AstraZeneca 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 27 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 6 Dec 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 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. 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?
Area under plasma concentration-time curve from zero to infinity (AUCinf) (Treatment A versus Treatment C) (time frame: Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)). The study lists 8 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 6 Dec 2021.