HealthyPhase 1NCT05026567
Bioavailability Study of Midazolam Administered as a Solution by Conventional Syringe or ZENEO®
A Phase 1 study testing 2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL), ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thigh and ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal area in people with Healthy, run by Crossject at 1 site in South Africa.
Trial summary
Primary objective of this study is to describe the plasma pharmacokinetics of midazolam after single intramuscular injection on bare skin in the thigh by the needle-free injector Zeneo® compared to injection on bare skin in the thigh by a conventional syringe (Reference) in terms of relative bioavailability and… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL), ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thigh and ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal area
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Africa
- Study dates
- 9 May 2022to 15 Jul 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females, 18 to 59 years (inclusive) at screening.
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive).
- Body mass weight between 50 and 110 kg (inclusive)
- Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
- Non-smokers or past-smokers who stopped at least 3 months before the study.
- Female subject must be either of
Show all 11Show fewer
- non-childbearing potential: post-menopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening).
- or, if of childbearing potential, must have a negative serum pregnancy test at Screening and must use two forms of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days [or 5 half-lives of the study drug whichever is longer] after the final study drug administration. Acceptable forms of birth control include: placement of a non-hormonal intrauterine device or intrauterine system, 2) barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) or abstinence of male/female intercourse if it is a part of normal practice in her life.
- The use of hormonal contraception in this study is not allowed. For male subjects contraception is not needed during this study.
- Injection sites must be clear of tattoos, scars and moles.
- Signed written consent given for participation in the study.
Who cannot join
- Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease, as judged by the Investigator.
- Medical history of malignant disease (with the exception of localized skin or cervical carcinoma that had been excised and cured)
- Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or admission to the clinical unit.
- A pulse < 40 or > 100 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (measurements taken in triplicate after subject has been resting in supine position for 5 minutes.
- A mean corrected QT interval using Fridericia's formula (QTcF) interval > 450 ms at screening. If the mean QTcF exceeds the limits above, one additional triplicate ECG may be taken. If this triplicate also gives an abnormal result, the subject should be excluded.
- History of smoking within 3 months prior to the first admission to the clinical unit.
Show all 26Show fewer
- History of drinking more than 21 units of alcohol per week (1 unit = 10 g pure alcohol = 250 ml of beer [5%] or 35 ml of spirits [35%] or 100 ml of wine [12%]) within 3 months prior to the first admission to the clinical unit.
- Any recreational use of drugs-of-abuse within 3 months prior to the first administration of an IMP.
- Use of any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to first study medication administration, except for the occasional use of paracetamol (up to 2 g/day)- except if it will not affect the study outcome at the discretion of the investigator.
- Use of drugs that induce hepatic enzymes (rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, and aminoglutethimide).
- Use of inhibitors of the CYP3A4 enzyme (including but not only clarithromycin, itraconazole, erythromycin, fluconazole, verapamil). (https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers)
- Participation in any clinical study within 3 months prior to the expected date of enrolment into the clinical study, provided that the clinical study did not entail a biological compound with a long half-life or participation in more than 3 clinical studies within 12 months.
- Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.
- A major illness during the 3 months before commencement of the screening period.
- Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
- Any significant blood loss, donated one unit (450 m) of blood or more, or received a transfusion of any blood or blood products within 60 days, or donated plasma within 7 days prior to the first admission to the clinical unit.
- History of hypersensitivity or allergy to the IMP or its excipients or any related medication.
- The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical study, including any conditions mentioned in contraindication, special warnings and precautions for use, in the summary of product characteristics of the IMP.
- History of COVID illness in last 30 days.
- Positive serology test for hepatitis B surface antigen, hepatitis C virus antibodies or human immunodeficiency virus-1 and/or 2 antibodies.
- Positive pregnancy test.
- Positive urine screen for drugs of abuse. In case of a positive result the urine screen for drugs of abuse may be repeated once at the discretion of the investigator.
- Positive urine screen for tobacco use.
- Any specific investigational product safety concern.
- Vulnerable subjects, e.g. persons in detention.
- Employee of the sponsor (or authorized representative), or FARMOVS (or authorized representative)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Single Dose, Open Label, Randomized, Four-period Crossover Study in Healthy Subjects to Describe and Compare the Plasma Pharmacokinetics of Midazolam After Intramuscular Injection as a Solution by a Conventional Syringe or by the Needle-free Injector ZENEO®
Primary objective of this study is to describe the plasma pharmacokinetics of midazolam after single intramuscular injection on bare skin in the thigh by the needle-free injector Zeneo® compared to injection on bare skin in the thigh by a conventional syringe (Reference) in terms of relative bioavailability and bioequivalence.
Read the detailed description
Secondary objectives are:
- To describe the plasma pharmacokinetics of midazolam after single intramuscular injection on bare skin in the ventrogluteal area by the needle-free injector Zeneo® compared to injection on bare skin in the thigh by a conventional syringe (Reference) in terms of relative bioavailability and bioequivalence.
- To describe the plasma pharmacokinetics of midazolam after single intramuscular injection through clothing in the thigh by the needle-free injector Zeneo® compared to injection on bare skin in the thigh by a conventional syringe (Reference) in terms of relative bioavailability and bioequivalence.
- To describe the plasma pharmacokinetics of midazolam after single intramuscular injection through clothing in the thigh by the needle-free injector Zeneo® compared to injection on bare skin in the thigh by the needle-free injector Zeneo® in terms of relative bioavailability and bioequivalence.
- To describe the plasma pharmacokinetics of midazolam after single intramuscular injection on bare skin in the thigh by the needle-free injector Zeneo® compared to injection on bare skin in the ventrogluteal area by the needle-free injector Zeneo® in terms of relative bioavailability and bioequivalence
- To assess and compare the pharmacokinetics of the major active metabolite 1'-OH midazolam after a single intramuscular injection i.m. administration when delivered by ZENEO®® orvs. administration by conventional syringe (Reference)conventional syringe with needle.
- To assess and compare the pharmacokinetics of ZENEO® Midazolam (10mg / 0.625mL) administered in the thigh on bare skin and ZENEO® Midazolam (10mg / 0.625mL) administered in the thigh through clothing.
- To assess safety and tolerability of midazolam after a single intramuscular injection single i.m. administration whenby delivered by ZENEO® vs. administrationor by conventional syringe (Reference) by conventional syringe with needle.
- Conditions
- Healthy
- Being tested
- 2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL), ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thigh, ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal area, ZENEO® Midazolam (10 mg / 0.625 mL) through clothing in thigh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL)Drug
Intramuscular injection
ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thighCombination product
Intramuscular injection
ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal areaCombination product
Intramuscular injection
ZENEO® Midazolam (10 mg / 0.625 mL) through clothing in thighCombination product
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Reference Product A | Active comparator | Not described Receives: Drug: 2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL) |
| Experimental B | Experimental | Not described Receives: Combination Product: ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thigh |
| Experimental C | Experimental | Not described Receives: Combination Product: ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal area |
| Experiment D | Experimental | Not described Receives: Combination Product: ZENEO® Midazolam (10 mg / 0.625 mL) through clothing in thigh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve, time zero to time of the last quantifiable concentration (AUC0-t)
Measured: up to 36hours
Area under the plasma concentration versus time curve, with extrapolation to infinity (AUC0-∞)
Measured: up to 36hours
Maximum observed plasma concentration Cmax
Measured: up to 36hours
Secondary outcomes (9)
Time to peak drug concentration (Tmax) of midazolam
Measured: up to 36 hours
Terminal half-life (T1/2) of midazolam
Measured: up to 36 hours
Time to peak drug concentration (Tmax) of 1'OH-midazolam
Measured: up to 36 hours
Terminal half-life (T1/2) of 1'OH-midazolam
Measured: up to 36 hours
Maximum observed plasma concentration (Cmax) 1'OH-midazolam
Measured: up to 36 hours
Area under the plasma concentration versus time curve from time 0 to the last measurable concentration (AUC0-t) of 1'OH-midazolam
Measured: up to 36 hours
Area under the plasma concentration versus time curve from time 0 extrapolated to infinite time (AUC0- ∞) of 1'OH-midazolam
Measured: up to 36 hours
Pain evaluation using the visual analogue scale (0:no pain-10:pain as bad as it could possibly be)
Measured: up to 5 hours
Number of Safety/adverse events
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start9 May 2022
- Primary completion14 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crossject
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- EFW Krantz, PhD, Principal investigator, Farmovs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026567
- Sponsor's protocol ID
- CJTPKL172001
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lacombe O, Pletan Y, Grouin JM, Brennan A, Gire O. Relative Bioavailability Study of Midazolam Intramuscularly Administered with the Needle-Free Auto-Injector ZENEO(R) in Healthy Adults. Neurol Ther. 2024 Aug;13(4):1155-1172. doi: 10.1007/s40120-024-00627-4. Epub 2024 May 28.
PubMed 38806873
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Single Dose, Open Label, Randomized, Four-period Crossover Study in Healthy Subjects to Describe and Compare the Plasma Pharmacokinetics of Midazolam After Intramuscular Injection as a Solution by a Conventional Syringe or by the Needle-free Injector ZENEO®
- ClinicalTrials.gov ID
- NCT05026567
- Acronym / sponsor ID
- CJTPKL172001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CrossjectIndustry (pharma, biotech, devices)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 30 Aug 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.
Primary objective of this study is to describe the plasma pharmacokinetics of midazolam after single intramuscular injection on bare skin in the thigh by the needle-free injector Zeneo® compared to injection on bare skin in the thigh by a conventional syringe (Reference) in terms of relative bioavailability and bioequivalence.
Detailed description
Secondary objectives are:
- To describe the plasma pharmacokinetics of midazolam after single intramuscular injection on bare skin in the ventrogluteal area by the needle-free injector Zeneo® compared to injection on bare skin in the thigh by a conventional syringe (Reference) in terms of relative bioavailability and bioequivalence.
- To describe the plasma pharmacokinetics of midazolam after single intramuscular injection through clothing in the thigh by the needle-free injector Zeneo® compared to injection on bare skin in the thigh by a conventional syringe (Reference) in terms of relative bioavailability and bioequivalence.
- To describe the plasma pharmacokinetics of midazolam after single intramuscular injection through clothing in the thigh by the needle-free injector Zeneo® compared to injection on bare skin in the thigh by the needle-free injector Zeneo® in terms of relative bioavailability and bioequivalence.
- To describe the plasma pharmacokinetics of midazolam after single intramuscular injection on bare skin in the thigh by the needle-free injector Zeneo® compared to injection on bare skin in the ventrogluteal area by the needle-free injector Zeneo® in terms of relative bioavailability and bioequivalence
- To assess and compare the pharmacokinetics of the major active metabolite 1'-OH midazolam after a single intramuscular injection i.m. administration when delivered by ZENEO®® orvs. administration by conventional syringe (Reference)conventional syringe with needle.
- To assess and compare the pharmacokinetics of ZENEO® Midazolam (10mg / 0.625mL) administered in the thigh on bare skin and ZENEO® Midazolam (10mg / 0.625mL) administered in the thigh through clothing.
- To assess safety and tolerability of midazolam after a single intramuscular injection single i.m. administration whenby delivered by ZENEO® vs. administrationor by conventional syringe (Reference) by conventional syringe with needle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reference Product A | Active comparator | Drug: 2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL) |
| Experimental B | Experimental | Combination Product: ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thigh |
| Experimental C | Experimental | Combination Product: ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal area |
| Experiment D | Experimental | Combination Product: ZENEO® Midazolam (10 mg / 0.625 mL) through clothing in thigh |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy males and females, 18 to 59 years (inclusive) at screening.
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive).
- Body mass weight between 50 and 110 kg (inclusive)
- Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
- Non-smokers or past-smokers who stopped at least 3 months before the study.
Key exclusion criteria (26 listed)
- Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease, as judged by the Investigator.
- Medical history of malignant disease (with the exception of localized skin or cervical carcinoma that had been excised and cured)
- Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or admission to the clinical unit.
- A pulse < 40 or > 100 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (measurements taken in triplicate after subject has been resting in supine position for 5 minutes.
- A mean corrected QT interval using Fridericia's formula (QTcF) interval > 450 ms at screening. If the mean QTcF exceeds the limits above, one additional triplicate ECG may be taken. If this triplicate also gives an abnormal result, the subject should be excluded.
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 |
|---|---|---|
| 2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL)Intramuscular injection | Drug | Reference Product A |
| ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thighIntramuscular injection | Combination product | Experimental B |
| ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal areaIntramuscular injection | Combination product | Experimental C |
| ZENEO® Midazolam (10 mg / 0.625 mL) through clothing in thighIntramuscular injection | Combination product | Experiment D |
Primary outcome
Area under the plasma concentration versus time curve, time zero to time of the last quantifiable concentration (AUC0-t)
Time frame: up to 36hours
Area under the plasma concentration versus time curve, with extrapolation to infinity (AUC0-∞)
Time frame: up to 36hours
Maximum observed plasma concentration Cmax
Time frame: up to 36hours
9 secondary outcomes
Time to peak drug concentration (Tmax) of midazolam
Time frame: up to 36 hours
Terminal half-life (T1/2) of midazolam
Time frame: up to 36 hours
Time to peak drug concentration (Tmax) of 1'OH-midazolam
Time frame: up to 36 hours
Terminal half-life (T1/2) of 1'OH-midazolam
Time frame: up to 36 hours
Maximum observed plasma concentration (Cmax) 1'OH-midazolam
Time frame: up to 36 hours
Area under the plasma concentration versus time curve from time 0 to the last measurable concentration (AUC0-t) of 1'OH-midazolam
Time frame: up to 36 hours
Area under the plasma concentration versus time curve from time 0 extrapolated to infinite time (AUC0- ∞) of 1'OH-midazolam
Time frame: up to 36 hours
Pain evaluation using the visual analogue scale (0:no pain-10:pain as bad as it could possibly be)
Time frame: up to 5 hours
Number of Safety/adverse events
Time frame: 7 days
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 22 Jul 2022.
- Derived from this study: PubMed 38806873Lacombe O, Pletan Y, Grouin JM, Brennan A, Gire O. Relative Bioavailability Study of Midazolam Intramuscularly Administered with the Needle-Free Auto-Injector ZENEO(R) in Healthy Adults. Neurol Ther. 2024 Aug;13(4):1155-1172. doi: 10.1007/s40120-024-00627-4. Epub 2024 May 28.
- Individual participant dataSharing planned: No
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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.
EFW Krantz, PhD principal investigator
Farmovs
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 2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL), ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thigh and ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal area in people with Healthy, run by Crossject at 1 site in South Africa.
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 11 inclusion and 26 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 22 Jul 2022. 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 South Africa. 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 the plasma concentration versus time curve, time zero to time of the last quantifiable concentration (AUC0-t) (time frame: up to 36hours). The study lists 3 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 NCT05026567, which also lists 1 linked publication.
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 22 Jul 2022.