Filariasis, LymphaticPhase 1AWOLNCT05084560
Development of AWZ1066S, a Small Molecule Anti-Wolbachia Candidate Macrofilaricide Drug
A Phase 1 study testing AWZ1066S in people with Filariasis, Lymphatic and Onchocerciasis, run by Liverpool School of Tropical Medicine at 1 site in United Kingdom.
Trial summary
Lymphatic filariasis and onchocerciasis are a group of neglected tropical diseases caused by the transmission of worm larvae (microfilaria) by biting insects. Once a human is infected, the larvae mature into adult worms that release huge numbers of larvae into the lymphatics for 5-15 years. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Filariasis, Lymphatic, Onchocerciasis
- What is being tested?
- AWZ1066S
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Dec 2021to 22 May 2023
- 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
- 1. Healthy male and female participants 2 aged 18-65 years 3 BMI 18.0-35.0 kg/m2, maximum weight 100 kg 4 in good health, as determined by: 4a medical history, 4b physical examination, 4c vital signs assessment, 4d 12-lead ECG 4e clinical laboratory evaluations 5 provision of informed consent and abide by study restrictions
Who cannot join
- not willing to abide by contraception restrictions
- donated blood in previous 3 months, plasma previous 7 days, platelets previous 6 weeks
- consumption >14 units of alcohol/week
- tobacco smoking
- concomitant medication, apart from treatments for mild asthma, eczema, contraception, paracetamol
- herbal remedies
Show all 11Show fewer
- history of anaphylaxis, drug allergy, clinically significant atopic condition as determined by Investigator
- clinically significant medical history, as determined by the Investigator
- positive hepatitis, HIV serology
- live vaccine in previous 3 months, Covid-19 vaccine prior 14 days
- Participants who, in the opinion of the Investigator, should not participate in this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool University Hospitals NHS Foundation Trust
Liverpool, Merseyside
About this study
Lymphatic filariasis and onchocerciasis are a group of neglected tropical diseases caused by the transmission of worm larvae (microfilaria) by biting insects. Once a human is infected, the larvae mature into adult worms that release huge numbers of larvae into the lymphatics for 5-15 years. The larvae cause tissue damage resulting in the disabling diseases of elephantiasis (gross leg and scrotal swelling) and river blindness. These diseases affect 160 million people and are acknowledged major public health problems in the tropics. Current treatments mainly target the larvae but not the adult worms that live for years, meaning that repeated courses of treatment over many years are needed. These repeated courses are usually delivered at population level in the form of mass drug administration programmes.
For the adult worms to be able to grow, reproduce and infect more humans they are dependent on a bacterium which lives inside them. This bacterium (Wolbachia) is not naturally found in humans. Some drugs are able to target Wolbachia, however they are unsuitable for mass drug administration programmes because they have to be given for 4-6 weeks and cannot be used in children or pregnant women.
AWZ1066S is a novel drug developed in Liverpool that has been shown in experimental models to target Wolbachia and indirectly kill the adult parasitic worms after a 7 day course. After extensive safety testing in animals we are conducting a Phase 1, first in human study, to assess the safety, tolerability and pharmacokinetics of ascending single and multiple oral doses of AWZ1066S in healthy volunteers. The study is a single centre study, will last approximately 1 year and will take place in a dedicated Phase 1 trial unit. Depending on which group they are enrolled into, participants will take either one dose, two doses or seven doses and their involvement will last between 38 and 45 days. Participants will be closely monitored for adverse effects.
Read the detailed description
AWZ1066S is in the early stages of clinical development, for safety reasons, a sequential, ascending dose design is being used. The study is double-blind, and placebo controlled. All research activities will be conducted within a dedicated Phase 1 Clinical Research Facility.
Part A comprises a single ascending dose design with an overall group total of 48 participants. These will be studied in 6 cohorts (Cohorts A1 to A6), with each cohort consisting of 8 participants (6 randomised to oral dose of AWZ1066S and 2 randomised to placebo). Each participant will receive single dose of AWZ1066S, apart from cohort A4 participants who will take a single dose when fasting and and a single dose when fed, separated by a minimum of 7 days.
The planned doses for Part A are:
Cohort A1- 100mg Cohort A2- 200mg Cohort A3- 400mg Cohort A4- 800mg fasted and 800mg fed Cohort A5- 1200mg Cohort A6- 1600mg Participants will receive their dose whilst resident in the Clinical Research Facility and will return for outpatient visits on Day 3, 4 and 10 safety assessments and pharmacokinetic blood samples.
Part B comprises a multiple ascending dose design, to investigate 4 dose levels in four cohorts (cohorts B1 to B4) with each cohort consisting of 8 participants (6 randomised to oral dose of AWZ1066S and 2 randomized to placebo). The doses investigated will be selected following review of data from the single dosing study (Part A). The intention is to enrol a minimum 32 healthy participants. Each participant will receive single daily dose of AWZ1066S for 7 days. Participants will receive their dose whilst resident in the Clinical Research Facility and will return for outpatient visits on Day 3, 5, 9 and 10 for safety assessments and pharmacokinetic blood samples. A second resident period on Day 6 to Day 8 will allow pharmacokinetic blood samples and safety assessments.
Safety and tolerability will be monitored by adverse events, vital signs, ECGs, urinalysis, routine haematology and biochemistry. Escalation of dosing will only take place after examination of safety data by the Dose Escalation Committee.
- Conditions
- Filariasis, Lymphatic, Onchocerciasis
- Being tested
- AWZ1066S, Placebo
- Keywords
- Lymphatic filariasis, Onchocerciasis, Wolbachia, Phase 1, Healthy volunteers, Randomized, Double blind, Placebo
- Medical subject headings
- Elephantiasis, Filarial, Onchocerciasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWZ1066SDrug
Candidate drug to treat lymphatic filariasis by targeting Wolbachia endosymbiont
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AWZ1066S | Experimental | AWZ1066S
Part A Cohort A1- 100mg single dose Cohort A2- 200mg single dose Cohort A3- 400mg single dose Cohort A4- 800mg fasted single dose and 800mg fed single dose Cohort A5- 1200mg single dose Cohort A6- 1600mg single dose
The doses for part B will be selected following review of data from Part A. Cohort B1- AWZ1066S once daily for 7 days Cohort B2- AWZ1066S once daily for 7 days Cohort B3- AWZ1066S once daily for 7 days Cohort B4- AWZ1066S once daily for 7 days Receives: Drug: AWZ1066S |
| Placebo | Placebo comparator | Placebo
Cohort A1- equivalent placebo single dose Cohort A2- equivalent placebo single dose Cohort A3- equivalent placebo single dose Cohort A4- equivalent placebo fasted single dose and equivalent placebo fed single dose Cohort A5- equivalent placebo single dose Cohort A6- equivalent placebo single dose
The doses for part B will be selected following review of data from Part A. Cohort B1- equivalent placebo once daily for 7 days Cohort B2- equivalent placebo once daily for 7 days Cohort B3- equivalent placebo once daily for 7 days Cohort B4- equivalent placebo once daily for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Number
Measured: From day of first dose to 10 days after last dose
Secondary outcomes (8)
Single dose pharmacokinetics Cmax
Pharmacokinetic parameter, maximum plasma concentration (Cmax)
Measured: From day of first dose to 10 days after last dose
Single dose pharmacokinetics tmax
Pharmacokinetic parameter, time to reach maximum plasma concentration (tmax)
Measured: From day of first dose to 10 days after last dose
Single dose pharmacokinetics t1/2
Pharmacokinetic parameter, half life (t1/2)
Measured: From day of first dose to 10 days after last dose
Single dose pharmacokinetics CL/F
Pharmacokinetic parameter, apparent total clearance after oral administration (CL/F)
Measured: From day of first dose to 10 days after last dose
Multiple dose pharmacokinetics Cmax
Pharmacokinetic parameter, maximum plasma concentration (Cmax)
Measured: From day of first dose to 10 days after last dose
Multiple dose pharmacokinetics tmax
Pharmacokinetic parameter, time to reach maximum plasma concentration (tmax)
Measured: From day of first dose to 10 days after last dose
Multiple dose pharmacokinetics t1/2
Pharmacokinetic parameter, half life (t1/2)
Measured: From day of first dose to 10 days after last dose
Multiple dose pharmacokinetics CL/f
Pharmacokinetic parameter, apparent total clearance after oral administration (CL/F)
Measured: From day of first dose to 10 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 posted20 Oct 2021
- Study start10 Dec 2021
- Primary completion22 May 2023
- Study completion22 May 2023
Why it stopped: Safety issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Filariasis, LymphaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sequential, ascending dose design, double-blind, placebo controlled. Part A: single ascending dose design with 6 dosing levels. Part B: multiple ascending dose design with 4 dosing levels.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust, Covance, Subiaco Associates Limited, Sylexis Limited, Eisai Limited
- Responsible party
- Sponsor
- Investigators
- Graham Devereux, MD, Principal investigator, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084560
- Sponsor's protocol ID
- 21-059
- Acronym
- AWOL
- Status last verified
- Sep 2023
- First submitted
- 5 Oct 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Commercial sensitivity
Publications
Hong WD, Benayoud F, Nixon GL, Ford L, Johnston KL, Clare RH, Cassidy A, Cook DAN, Siu A, Shiotani M, Webborn PJH, Kavanagh S, Aljayyoussi G, Murphy E, Steven A, Archer J, Struever D, Frohberger SJ, Ehrens A, Hubner MP, Hoerauf A, Roberts AP, Hubbard ATM, Tate EW, Serwa RA, Leung SC, Qie L, Berry NG, Gusovsky F, Hemingway J, Turner JD, Taylor MJ, Ward SA, O'Neill PM. AWZ1066S, a highly specific anti-Wolbachia drug candidate for a short-course treatment of filariasis. Proc Natl Acad Sci U S A. 2019 Jan 22;116(4):1414-1419. doi: 10.1073/pnas.1816585116. Epub 2019 Jan 7.
PubMed 30617067Devereux G, Bula M, Tripp K, Fitzgerald R, Eraut N, Alam MS, Moriyama T, Shinkyo R, Walker L, Wang D, Gusovsky F, van der Velde J, Turner JD, Hong WD, O'Neill PM, Taylor MJ, Ward SA. A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Trial of AWZ1066S, an Anti-Wolbachia Candidate Macrofilaricide. Clin Pharmacol Drug Dev. 2024 Sep;13(9):1071-1081. doi: 10.1002/cpdd.1441. Epub 2024 Jun 24.
PubMed 38924387
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of AWZ1066S, a Small Molecule Anti-Wolbachia Candidate Macrofilaricide Drug
- ClinicalTrials.gov ID
- NCT05084560
- Acronym / sponsor ID
- AWOL / 21-059
- Conditions
- Filariasis, Lymphatic, Onchocerciasis
- Keywords
- Lymphatic filariasis, Onchocerciasis, Wolbachia, Phase 1, Healthy volunteers, Randomized, Double blind, Placebo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety issues
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust, Covance, Subiaco Associates Limited, Sylexis Limited, Eisai Limited
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 20 Oct 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.
Lymphatic filariasis and onchocerciasis are a group of neglected tropical diseases caused by the transmission of worm larvae (microfilaria) by biting insects. Once a human is infected, the larvae mature into adult worms that release huge numbers of larvae into the lymphatics for 5-15 years. The larvae cause tissue damage resulting in the disabling diseases of elephantiasis (gross leg and scrotal swelling) and river blindness. These diseases affect 160 million people and are acknowledged major public health problems in the tropics. Current treatments mainly target the larvae but not the adult worms that live for years, meaning that repeated courses of treatment over many years are needed. These repeated courses are usually delivered at population level in the form of mass drug administration programmes.
For the adult worms to be able to grow, reproduce and infect more humans they are dependent on a bacterium which lives inside them. This bacterium (Wolbachia) is not naturally found in humans. Some drugs are able to target Wolbachia, however they are unsuitable for mass drug administration programmes because they have to be given for 4-6 weeks and cannot be used in children or pregnant women.
AWZ1066S is a novel drug developed in Liverpool that has been shown in experimental models to target Wolbachia and indirectly kill the adult parasitic worms after a 7 day course. After extensive safety testing in animals we are conducting a Phase 1, first in human study, to assess the safety, tolerability and pharmacokinetics of ascending single and multiple oral doses of AWZ1066S in healthy volunteers. The study is a single centre study, will last approximately 1 year and will take place in a dedicated Phase 1 trial unit. Depending on which group they are enrolled into, participants will take either one dose, two doses or seven doses and their involvement will last between 38 and 45 days. Participants will be closely monitored for adverse effects.
Detailed description
AWZ1066S is in the early stages of clinical development, for safety reasons, a sequential, ascending dose design is being used. The study is double-blind, and placebo controlled. All research activities will be conducted within a dedicated Phase 1 Clinical Research Facility.
Part A comprises a single ascending dose design with an overall group total of 48 participants. These will be studied in 6 cohorts (Cohorts A1 to A6), with each cohort consisting of 8 participants (6 randomised to oral dose of AWZ1066S and 2 randomised to placebo). Each participant will receive single dose of AWZ1066S, apart from cohort A4 participants who will take a single dose when fasting and and a single dose when fed, separated by a minimum of 7 days.
The planned doses for Part A are:
Cohort A1- 100mg Cohort A2- 200mg Cohort A3- 400mg Cohort A4- 800mg fasted and 800mg fed Cohort A5- 1200mg Cohort A6- 1600mg Participants will receive their dose whilst resident in the Clinical Research Facility and will return for outpatient visits on Day 3, 4 and 10 safety assessments and pharmacokinetic blood samples.
Part B comprises a multiple ascending dose design, to investigate 4 dose levels in four cohorts (cohorts B1 to B4) with each cohort consisting of 8 participants (6 randomised to oral dose of AWZ1066S and 2 randomized to placebo). The doses investigated will be selected following review of data from the single dosing study (Part A). The intention is to enrol a minimum 32 healthy participants. Each participant will receive single daily dose of AWZ1066S for 7 days. Participants will receive their dose whilst resident in the Clinical Research Facility and will return for outpatient visits on Day 3, 5, 9 and 10 for safety assessments and pharmacokinetic blood samples. A second resident period on Day 6 to Day 8 will allow pharmacokinetic blood samples and safety assessments.
Safety and tolerability will be monitored by adverse events, vital signs, ECGs, urinalysis, routine haematology and biochemistry. Escalation of dosing will only take place after examination of safety data by the Dose Escalation Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sequential, ascending dose design, double-blind, placebo controlled. Part A: single ascending dose design with 6 dosing levels. Part B: multiple ascending dose design with 4 dosing levels.
| Arm | Type | Receives |
|---|---|---|
| AWZ1066S | Experimental | Drug: AWZ1066SAWZ1066S Part A Cohort A1- 100mg single dose Cohort A2- 200mg single dose Cohort A3- 400mg single dose Cohort A4- 800mg fasted single dose and 800mg fed single dose Cohort A5- 1200mg single dose Cohort A6- 1600mg single dose The doses for part B will be selected following review of data from Part A. Cohort B1- AWZ1066S once daily for 7 days Cohort B2- AWZ1066S once daily for 7 days Cohort B3- AWZ1066S once daily for 7 days Cohort B4- AWZ1066S once daily for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Cohort A1- equivalent placebo single dose Cohort A2- equivalent placebo single dose Cohort A3- equivalent placebo single dose Cohort A4- equivalent placebo fasted single dose and equivalent placebo fed single dose Cohort A5- equivalent placebo single dose Cohort A6- equivalent placebo single dose The doses for part B will be selected following review of data from Part A. Cohort B1- equivalent placebo once daily for 7 days Cohort B2- equivalent placebo once daily for 7 days Cohort B3- equivalent placebo once daily for 7 days Cohort B4- equivalent placebo once daily for 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Healthy male and female participants 2 aged 18-65 years 3 BMI 18.0-35.0 kg/m2, maximum weight 100 kg 4 in good health, as determined by: 4a medical history, 4b physical examination, 4c vital signs assessment, 4d 12-lead ECG 4e clinical laboratory evaluations 5 provision of informed consent and abide by study restrictions
Key exclusion criteria (11 listed)
- not willing to abide by contraception restrictions
- donated blood in previous 3 months, plasma previous 7 days, platelets previous 6 weeks
- consumption >14 units of alcohol/week
- tobacco smoking
- concomitant medication, apart from treatments for mild asthma, eczema, contraception, paracetamol
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 |
|---|---|---|
| AWZ1066SCandidate drug to treat lymphatic filariasis by targeting Wolbachia endosymbiont | Drug | AWZ1066S |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Adverse events
Time frame: From day of first dose to 10 days after last dose
Number
8 secondary outcomes
Single dose pharmacokinetics Cmax
Time frame: From day of first dose to 10 days after last dose
Single dose pharmacokinetics tmax
Time frame: From day of first dose to 10 days after last dose
Single dose pharmacokinetics t1/2
Time frame: From day of first dose to 10 days after last dose
Single dose pharmacokinetics CL/F
Time frame: From day of first dose to 10 days after last dose
Multiple dose pharmacokinetics Cmax
Time frame: From day of first dose to 10 days after last dose
Multiple dose pharmacokinetics tmax
Time frame: From day of first dose to 10 days after last dose
Multiple dose pharmacokinetics t1/2
Time frame: From day of first dose to 10 days after last dose
Multiple dose pharmacokinetics CL/f
Time frame: From day of first dose to 10 days after last dose
Results and safety
The study was stopped early (reason given: Safety issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 30617067Hong WD, Benayoud F, Nixon GL, Ford L, Johnston KL, Clare RH, Cassidy A, Cook DAN, Siu A, Shiotani M, Webborn PJH, Kavanagh S, Aljayyoussi G, Murphy E, Steven A, Archer J, Struever D, Frohberger SJ, Ehrens A, Hubner MP, Hoerauf A, Roberts AP, Hubbard ATM, Tate EW, Serwa RA, Leung SC, Qie L, Berry NG, Gusovsky F, Hemingway J, Turner JD, Taylor MJ, Ward SA, O'Neill PM. AWZ1066S, a highly specific anti-Wolbachia drug candidate for a short-course treatment of filariasis. Proc Natl Acad Sci U S A. 2019 Jan 22;116(4):1414-1419. doi: 10.1073/pnas.1816585116. Epub 2019 Jan 7.
- Derived from this study: PubMed 38924387Devereux G, Bula M, Tripp K, Fitzgerald R, Eraut N, Alam MS, Moriyama T, Shinkyo R, Walker L, Wang D, Gusovsky F, van der Velde J, Turner JD, Hong WD, O'Neill PM, Taylor MJ, Ward SA. A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Trial of AWZ1066S, an Anti-Wolbachia Candidate Macrofilaricide. Clin Pharmacol Drug Dev. 2024 Sep;13(9):1071-1081. doi: 10.1002/cpdd.1441. Epub 2024 Jun 24.
- Individual participant dataSharing planned: No. Commercial sensitivity
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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.
Graham Devereux, MD principal investigator
Liverpool School of Tropical Medicine
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 AWZ1066S in people with Filariasis, Lymphatic and Onchocerciasis, run by Liverpool School of Tropical Medicine 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 1 inclusion and 11 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: stopped early, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Safety issues). Results are not available in the source record.
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?
Adverse events (time frame: From day of first dose to 10 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05084560, which also lists 2 linked publications.
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 Sep 2023.