ScabiesPhase 1HEALTHNCT06918665
HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation
A Phase 1 study testing ivermectin infant formula preparation and Standard ivermectin 3mg tablet in people with Scabies, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
This is a clinical trial to compare two formulations of the drug ivermectin: the standard 3mg tablet formulation versus a newly developed infant formula preparation. The goal of the trial is to determine if the new formulation functions in the same way, tastes the same and causes no new side effects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Scabies
- What is being tested?
- ivermectin infant formula preparation and Standard ivermectin 3mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2027to 1 Aug 2027
- 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
- Adult aged over 18 years up to 55 years; and
- Body mass index of 18.0 - 32.0 kg/m2 with body weight ≥ 50.0 kg; and
- Medically healthy, determined by medical history, physical examination, no clinically significant abnormalities on baseline blood tests, vital signs (blood pressure, oxygen saturation and heart rate) as deemed by the study Doctor; and
- Females must be non-pregnant, non-lactating or postmenopausal for at least 1 year or surgically sterile for at least 6 months prior to dosing; and
- Sexually active, non-pregnant female participants will be required to use an effective form of contraception from 28 days prior to study until end of study; and
- Males must not have a pregnant partner and must agree to use condoms as a method of contraception from the time of signing informed consent until end of the study; and
- Must be willing and able to read, understand, and sign the participant information and consent form. Willing to comply with all study requirements, including the inpatient period and outpatient visits for the duration of the study; and
- Good venous access on at least one arm as assessed by study staff.
Who cannot join
- History of any clinically important cardiac, endocrinologic, haematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the study doctor; or
- Known allergy to ivermectin or taking a drug that interacts with ivermectin via the P-glycoprotein transport system (e.g. amiodarone, carvedilol, clarithromycin, clotrimazole); or
- Currently taking warfarin; or
- Known lactose intolerance or cow's protein intolerance; or
- Known elective surgery scheduled within the next 3 months; or
- Inability to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
This is a clinical trial to compare two formulations of the drug ivermectin: the standard 3mg tablet formulation versus a newly developed infant formula preparation. The goal of the trial is to determine if the new formulation functions in the same way, tastes the same and causes no new side effects. The trial will involve 52 participants who will be healthy adult volunteers. The participants will receive both formulations - the order they receive each formulation will be assigned randomly (similar to the toss of a coin).
Read the detailed description
Randomised open-label cross-over trial of 52 healthy adult volunteers comparing two ivermectin formulations: the standard tablet formulation, and a newly developed infant formula preparation. Participants will be randomised to receive one of these two formulations at the start of the trial and after a 21 day wash out period will be given the alternative formulation. Blood samples will be taken to determine serum drug concentrations. The bioequivalence, tolerability and drug-related adverse effects will be evaluated.
- Conditions
- Scabies
- Being tested
- ivermectin infant formula preparation, Standard ivermectin 3mg tablet
- Keywords
- ivermectin
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivermectin infant formula preparationDrug
The ivermectin infant formula preparation is produced by micronizing the standard 3mg ivermectin tablet and then blending it with Stage 1 infant formula (Blackmores brand) to produce a homogenous powder. This powder blend of ivermectin and infant formula is then filled into food grade clear capsules.
Standard ivermectin 3mg tabletDrug
standard 3mg ivermectin tablet
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 (standard 3mg ivermectin tablet then ivermectin infant formula preparation) | Active comparator | Ivermectin standard 3mg tablet
washout 21 days
ivermectin infant formula preparation Receives: Drug: ivermectin infant formula preparation; Drug: Standard ivermectin 3mg tablet |
| Sequence 2 (ivermectin infant formula preparation then standard ivermectin 3mg tablet) | Active comparator | ivermectin infant formula preparation
21 days washout
ivermectin standard 3mg tablet Receives: Drug: ivermectin infant formula preparation; Drug: Standard ivermectin 3mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ivermectin Area Under the Curve (AUC) 0-96h bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation)
The serum ivermectin Area Under the Curve (AUC) 0-96h for both the new infant formula preparation and the standard 3 mg tablet will be measured. Bioequivalence is defined as the 90% Confidence Interval (CI) of the geometric mean ratio of AUC 0-96h of the infant formula preparation relative to the standard 3mg tablet falling within 80-125%.
Measured: 31 days
Serum ivermectin Maximum Concentration (Cmax) bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation)
The serum ivermectin Maximum Concentration (Cmax) for both the new infant formula preparation and the standard 3 mg tablet will be measured. Bioequivalence is defined as the 90% Confidence Interval (CI) of the geometric mean ratio of Cmax of the infant formula preparation relative to the standard 3mg tablet falling within 80-125%.
Measured: 31 days
Secondary outcomes (2)
Safety as measured by the proportion of participants experiencing one or more drug-related adverse effect(s) with each ivermectin formulation
Proportion of participants who experience one or more drug-related adverse effects with each ivermectin formulation
Measured: 51 days
Palatability of the new infant formula preparation as measured by a visual analogue scale (VAS)
Palatability of the new infant formula preparation will be assessed using a visual analogue scale to assess bitterness and overall likeability. The scale used for this VAS tool will be 0 to 10. For the question on overall likeability, a higher score will correspond with a higher level of likeability. For the question on bitterness, a higher score will indicate a higher level of bitterness.
Measured: 51 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study startJan 2027 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Why it stopped: Difficulty in finalising the intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ScabiesStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe 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
- Model description
- Randomised, Open-Label Cross-over
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Sponsor
- Investigators
- Amanda Gwee, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918665
- Sponsor's protocol ID
- 118266
- Acronym
- HEALTH
- Status last verified
- Oct 2026
- First submitted
- 31 Mar 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Beginning 12 months following analysis and article publication, upon approval of the request, the following will be made available long-term for the use by future researchers from a recognised research institute whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accepts MCRI's condition for access: * Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures and appendices) * Trial Protocol, PICF
Publications
Hauschke D, Steinijans VW, Pigeot I. Bioequivalence Studies in Drug Development. Chichester: John Wiley; 2007
European Medicines Agency. (2010). Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/Corr). Available at https://www.tga.gov.au.
Yotsu RR, Fuller LC, Murdoch ME, van Brakel WH, Revankar C, Barogui MYT, Postigo JAR, Dagne DA, Asiedu K, Hay RJ. A global call for action to tackle skin-related neglected tropical diseases (skin NTDs) through integration: An ambitious step change. PLoS Negl Trop Dis. 2023 Jun 15;17(6):e0011357. doi: 10.1371/journal.pntd.0011357. eCollection 2023 Jun.
PubMed 37319139Engelman D, Marks M, Steer AC, Beshah A, Biswas G, Chosidow O, Coffeng LE, Lardizabal Dofitas B, Enbiale W, Fallah M, Gasimov E, Hopkins A, Jacobson J, Kaldor JM, Ly F, Mackenzie CD, McVernon J, Parnaby M, Rainima-Qaniuci M, Sokana O, Sankara D, Yotsu R, Yajima A, Cantey PT. A framework for scabies control. PLoS Negl Trop Dis. 2021 Sep 2;15(9):e0009661. doi: 10.1371/journal.pntd.0009661. eCollection 2021 Sep.
PubMed 34473725Ponsonby-Thomas E, Pham AC, Huang S, Salim M, Klein LD, Offersen SM, Thymann T, Boyd BJ. Human milk improves the oral bioavailability of the poorly water-soluble drug clofazimine. Eur J Pharm Biopharm. 2025 Feb;207:114604. doi: 10.1016/j.ejpb.2024.114604. Epub 2024 Dec 13.
PubMed 39675684Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981 Aug;30(2):239-45. doi: 10.1038/clpt.1981.154. No abstract available.
PubMed 7249508Gwee A, Steer A, Phongluxa K, Luangphaxay C, Senggnam K, Philavanh A, Lei A, Martinez A, Huang S, McWhinney B, Ungerer J, Duffull S, Yang W, Zhu X, Coghlan B. Ivermectin therapy for young children with scabies infection: a multicentre phase 2 non-randomized trial. Lancet Reg Health West Pac. 2024 Jul 13;49:101144. doi: 10.1016/j.lanwpc.2024.101144. eCollection 2024 Aug.
PubMed 39109221Karimkhani C, Colombara DV, Drucker AM, Norton SA, Hay R, Engelman D, Steer A, Whitfeld M, Naghavi M, Dellavalle RP. The global burden of scabies: a cross-sectional analysis from the Global Burden of Disease Study 2015. Lancet Infect Dis. 2017 Dec;17(12):1247-1254. doi: 10.1016/S1473-3099(17)30483-8. Epub 2017 Sep 21.
PubMed 28941561Dabira ED, Soumare HM, Conteh B, Ceesay F, Ndiath MO, Bradley J, Mohammed N, Kandeh B, Smit MR, Slater H, Peeters Grietens K, Broekhuizen H, Bousema T, Drakeley C, Lindsay SW, Achan J, D'Alessandro U. Mass drug administration of ivermectin and dihydroartemisinin-piperaquine against malaria in settings with high coverage of standard control interventions: a cluster-randomised controlled trial in The Gambia. Lancet Infect Dis. 2022 Apr;22(4):519-528. doi: 10.1016/S1473-3099(21)00557-0. Epub 2021 Dec 15.
PubMed 34919831
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation
- ClinicalTrials.gov ID
- NCT06918665
- Acronym / sponsor ID
- HEALTH / 118266
- Conditions
- Scabies
- Keywords
- ivermectin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Difficulty in finalising the intervention
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- Jan 2027 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 9 Apr 2025 (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 clinical trial to compare two formulations of the drug ivermectin: the standard 3mg tablet formulation versus a newly developed infant formula preparation. The goal of the trial is to determine if the new formulation functions in the same way, tastes the same and causes no new side effects. The trial will involve 52 participants who will be healthy adult volunteers. The participants will receive both formulations - the order they receive each formulation will be assigned randomly (similar to the toss of a coin).
Detailed description
Randomised open-label cross-over trial of 52 healthy adult volunteers comparing two ivermectin formulations: the standard tablet formulation, and a newly developed infant formula preparation. Participants will be randomised to receive one of these two formulations at the start of the trial and after a 21 day wash out period will be given the alternative formulation. Blood samples will be taken to determine serum drug concentrations. The bioequivalence, tolerability and drug-related adverse effects will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, Open-Label Cross-over
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (standard 3mg ivermectin tablet then ivermectin infant formula preparation) | Active comparator | Drug: ivermectin infant formula preparation, Drug: Standard ivermectin 3mg tabletIvermectin standard 3mg tablet washout 21 days ivermectin infant formula preparation |
| Sequence 2 (ivermectin infant formula preparation then standard ivermectin 3mg tablet) | Active comparator | Drug: ivermectin infant formula preparation, Drug: Standard ivermectin 3mg tabletivermectin infant formula preparation 21 days washout ivermectin standard 3mg tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adult aged over 18 years up to 55 years; and
- Body mass index of 18.0 - 32.0 kg/m2 with body weight ≥ 50.0 kg; and
- Medically healthy, determined by medical history, physical examination, no clinically significant abnormalities on baseline blood tests, vital signs (blood pressure, oxygen saturation and heart rate) as deemed by the study Doctor; and
- Females must be non-pregnant, non-lactating or postmenopausal for at least 1 year or surgically sterile for at least 6 months prior to dosing; and
- Sexually active, non-pregnant female participants will be required to use an effective form of contraception from 28 days prior to study until end of study; and
Key exclusion criteria (6 listed)
- History of any clinically important cardiac, endocrinologic, haematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the study doctor; or
- Known allergy to ivermectin or taking a drug that interacts with ivermectin via the P-glycoprotein transport system (e.g. amiodarone, carvedilol, clarithromycin, clotrimazole); or
- Currently taking warfarin; or
- Known lactose intolerance or cow's protein intolerance; or
- Known elective surgery scheduled within the next 3 months; or
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 |
|---|---|---|
| ivermectin infant formula preparationThe ivermectin infant formula preparation is produced by micronizing the standard 3mg ivermectin tablet and then blending it with Stage 1 infant formula (Blackmores brand) to produce a homogenous powder. This powder blend of ivermectin and infant formula is then filled into food grade clear capsules. | Drug | Sequence 1 (standard 3mg ivermectin tablet then ivermectin infant formula preparation), Sequence 2 (ivermectin infant formula preparation then standard ivermectin 3mg tablet) |
| Standard ivermectin 3mg tabletstandard 3mg ivermectin tablet | Drug | Sequence 1 (standard 3mg ivermectin tablet then ivermectin infant formula preparation), Sequence 2 (ivermectin infant formula preparation then standard ivermectin 3mg tablet) |
Primary outcome
Serum ivermectin Area Under the Curve (AUC) 0-96h bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation)
Time frame: 31 days
The serum ivermectin Area Under the Curve (AUC) 0-96h for both the new infant formula preparation and the standard 3 mg tablet will be measured. Bioequivalence is defined as the 90% Confidence Interval (CI) of the geometric mean ratio of AUC 0-96h of the infant formula preparation relative to the standard 3mg tablet falling within 80-125%.
Serum ivermectin Maximum Concentration (Cmax) bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation)
Time frame: 31 days
The serum ivermectin Maximum Concentration (Cmax) for both the new infant formula preparation and the standard 3 mg tablet will be measured. Bioequivalence is defined as the 90% Confidence Interval (CI) of the geometric mean ratio of Cmax of the infant formula preparation relative to the standard 3mg tablet falling within 80-125%.
2 secondary outcomes
Safety as measured by the proportion of participants experiencing one or more drug-related adverse effect(s) with each ivermectin formulation
Time frame: 51 days
Palatability of the new infant formula preparation as measured by a visual analogue scale (VAS)
Time frame: 51 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- BackgroundHauschke D, Steinijans VW, Pigeot I. Bioequivalence Studies in Drug Development. Chichester: John Wiley; 2007
- BackgroundEuropean Medicines Agency. (2010). Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/Corr). Available at https://www.tga.gov.au.
- Background: PubMed 37319139Yotsu RR, Fuller LC, Murdoch ME, van Brakel WH, Revankar C, Barogui MYT, Postigo JAR, Dagne DA, Asiedu K, Hay RJ. A global call for action to tackle skin-related neglected tropical diseases (skin NTDs) through integration: An ambitious step change. PLoS Negl Trop Dis. 2023 Jun 15;17(6):e0011357. doi: 10.1371/journal.pntd.0011357. eCollection 2023 Jun.
- Background: PubMed 34473725Engelman D, Marks M, Steer AC, Beshah A, Biswas G, Chosidow O, Coffeng LE, Lardizabal Dofitas B, Enbiale W, Fallah M, Gasimov E, Hopkins A, Jacobson J, Kaldor JM, Ly F, Mackenzie CD, McVernon J, Parnaby M, Rainima-Qaniuci M, Sokana O, Sankara D, Yotsu R, Yajima A, Cantey PT. A framework for scabies control. PLoS Negl Trop Dis. 2021 Sep 2;15(9):e0009661. doi: 10.1371/journal.pntd.0009661. eCollection 2021 Sep.
- Background: PubMed 39675684Ponsonby-Thomas E, Pham AC, Huang S, Salim M, Klein LD, Offersen SM, Thymann T, Boyd BJ. Human milk improves the oral bioavailability of the poorly water-soluble drug clofazimine. Eur J Pharm Biopharm. 2025 Feb;207:114604. doi: 10.1016/j.ejpb.2024.114604. Epub 2024 Dec 13.
- Background: PubMed 7249508Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981 Aug;30(2):239-45. doi: 10.1038/clpt.1981.154. No abstract available.
- Background: PubMed 39109221Gwee A, Steer A, Phongluxa K, Luangphaxay C, Senggnam K, Philavanh A, Lei A, Martinez A, Huang S, McWhinney B, Ungerer J, Duffull S, Yang W, Zhu X, Coghlan B. Ivermectin therapy for young children with scabies infection: a multicentre phase 2 non-randomized trial. Lancet Reg Health West Pac. 2024 Jul 13;49:101144. doi: 10.1016/j.lanwpc.2024.101144. eCollection 2024 Aug.
- Background: PubMed 28941561Karimkhani C, Colombara DV, Drucker AM, Norton SA, Hay R, Engelman D, Steer A, Whitfeld M, Naghavi M, Dellavalle RP. The global burden of scabies: a cross-sectional analysis from the Global Burden of Disease Study 2015. Lancet Infect Dis. 2017 Dec;17(12):1247-1254. doi: 10.1016/S1473-3099(17)30483-8. Epub 2017 Sep 21.
- Background: PubMed 34919831Dabira ED, Soumare HM, Conteh B, Ceesay F, Ndiath MO, Bradley J, Mohammed N, Kandeh B, Smit MR, Slater H, Peeters Grietens K, Broekhuizen H, Bousema T, Drakeley C, Lindsay SW, Achan J, D'Alessandro U. Mass drug administration of ivermectin and dihydroartemisinin-piperaquine against malaria in settings with high coverage of standard control interventions: a cluster-randomised controlled trial in The Gambia. Lancet Infect Dis. 2022 Apr;22(4):519-528. doi: 10.1016/S1473-3099(21)00557-0. Epub 2021 Dec 15.
- Individual participant dataSharing planned: Yes. Beginning 12 months following analysis and article publication, upon approval of the request, the following will be made available long-term for the use by future researchers from a recognised research institute whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accepts MCRI's condition for access: * Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures and appendices) * Trial Protocol, PICF
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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.
Amanda Gwee principal investigator
Murdoch Childrens Research Institute
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 ivermectin infant formula preparation and Standard ivermectin 3mg tablet in people with Scabies, run by Murdoch Childrens Research Institute 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 6 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: paused, as of the sponsor's last update on 9 Oct 2026. 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. 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?
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?
Serum ivermectin Area Under the Curve (AUC) 0-96h bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation) (time frame: 31 days). The study lists 2 primary outcomes in all. 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 NCT06918665, which also lists 9 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 9 Oct 2026.