Healthy Adult SubjectsPhase 1NCT06929052
A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in Healthy Subjects.
A Phase 1 study testing ADL-018 Autoinjector and ADL-018 Injection in people with Healthy Adult Subjects, run by Kashiv BioSciences, LLC at 1 site in Canada.
Trial summary
The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference Product (B): ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- ADL-018 Autoinjector and ADL-018 Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2025to 30 Aug 2025
- 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
- Age: 18 to 65 years of age, inclusive, at the time of dosing.
- Subject should be having serum total IgE ≤ 100 IU/ml at the time of screening
- Gender: Male and/or non-pregnant, non-lactating female. Female of childbearing potential must have a negative serum pregnancy test performed within 28 days prior to dosing day.
- Male subjects and/or female subject's partner must agree to use acceptable form of contraception which includes vasectomy, or use condoms, or spermicide in addition to female contraception for additional protection against conception from screening until 156 days after administration of the study medication.
- For female of childbearing potential, must agree to use acceptable forms of contraception from screening until 156 days after administration of the
- Investigational Product include the following:
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- Non hormonal intrauterine device in place, or Barrier methods containing or used in conjunction with a spermicidal agent, or Surgical sterilization or Practicing sexual abstinence.
- Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- Postmenopausal with spontaneous amenorrhea for at least one year, or Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level > 40 IU/L, or Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or Total hysterectomy and an absence of bleeding for at least 3 months.
- BMI: 18.5 to 32.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g., 32.04 rounds down to 32.0, while 18.49 rounds up to 18.5).
- Volunteers having body weight ≥50.0 kg or ≤ 90.0 kg.
- Able to communicate effectively with study personnel.
- Willing to provide written informed consent to participate in the study.
- Non-smokers and non-tobacco users (i.e., having no past history of smoking and tobacco consuming for at least one year prior to study).
- All volunteers must be judged by the principal and /or sub investigator principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the study medication administration which will include:
- A comprehensive physical examination, medical history, vital sign assessments, 12-lead electrocardiogram (ECG) with no clinically significant finding.
Who cannot join
- History of allergic responses to study drug or other related drugs, or any of its formulation ingredients.
- History of allergic reactions or sensitivity to latex or latex derived products.
- Have significant diseases or clinically significant abnormal findings during screening [medical history, comprehensive physical examination, vital signs, laboratory evaluations and ECG].
- Any disease or condition like diabetes, psychosis or others, which might compromise the hemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- History of helminthic or parasitic infection.
- History of immunological disorders or presence of bronchial asthma.
Show all 27Show fewer
- Use of any hormone replacement therapy within 3 months prior to the study medication administration.
- Use of any depot injection or implant of any drug within 3 months prior to the study medication administration.
- Use of CYP enzyme inhibitors or inducers or St. John's Wort within 30 days prior to the study medication administration (see https://druginteractions. medicine.iu.edu/MainTable.aspx).
- Reports a history of drug or alcohol addiction or abuse within the past 1 year.
- History or evidence of drug dependence.
- History of difficulty with donating blood or difficulty in accessibility of veins.
- A positive hepatitis screen (hepatitis B surface antigen, hepatitis C antibody).
- A positive test result for HIV antibody.
- Demonstrates a positive drug screen, cotinine, or alcohol test during screening
- Volunteers who have received any investigational drug/product within 30 days prior to the study medication administration.
- Volunteers who have donated blood or loss of blood between 101 mL to 499 mL within 30 days prior to dosing or a blood donation of more than 499 mL within 56 days prior to dosing for male volunteers and 84 days prior to dosing for female volunteers.
- Intolerance to venipuncture Demonstrates, in the opinion of the study staff, inadequate vein or vein unsuitable for repeated venipuncture (e.g. vein difficult to locate, access or puncture, vein with a tendency to rupture during or after puncture).
- 20) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer's participation in this study. 21) If, in the opinion of the investigator, the subject is not suitable for the study.
- 22) Institutionalized volunteers. 23) Use of any prescribed medications and/or Monoamine Oxidase Inhibitor (MAOI) within 14 days prior to the study medication administration. 24) Use of any herbal or dietary supplements or over-the-counter medications (Tylenol, Advil, etc.) or therapeutic dose of vitamins (including vitamin water) products, etc., within 7 days prior to the study medication administration. 25) Use of any products containing Seville oranges, grapefruit and pomelo within 7 days prior to the study medication administration.
- 26) Use of any products containing broccoli, brussels sprouts, and char-grilled meat within 14 days prior to the study medication administration.
- 27) Ingestion of any caffeine/xanthine containing products (coffee, tea, soft drinks, chocolate, energy drinks, etc.), alcohol and/or other alcohol containing products, foods containing poppy seeds within 48 hours prior to the study medication administration. 28) Ingestion of any beverages containing more than 5% fruit juice (fruit drinks, fruit punches, fruit cocktails, fruit , or other products containing 5% or less of fruit juice will be allowed) within 48 hours prior to the study medication administration. 29) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the study medication administration.
- 30) History of anaphylactic shock. 31) History of being on allergy vaccine therapy. 32) Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 90 days prior to the study medication administration.
- Subjects with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved. 34) Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 3 months before dosing.
- 35) Pregnant, breastfeeding, or intends to become pregnant over the course of the study.
- 36) Difficulty in fasting or consuming standardized meals. 37) Reports a clinically significant illness during the 28 days prior to dosing (as determined by the investigator and/or designee). 38) Reports undergoing any kind of surgical procedures with general anesthesia within 3 months prior to dosing.
- 39) Presence of tattoos or other skin conditions on both the left and right upper outer arms at the injection site based on PI discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Balanced, Two-treatment, Single Period, Parallel, Single Dose, Subcutaneous Administration, Comparative Pharmacokinetic Study of ADL-018 Injection 150 mg/mL Solution in a Single Dose Pre-filled Autoinjector Compared to ADL-018 Injection 150mg/mL Solution in a Single Dose Pre-filled Syringe in Normal, Healthy, Adult Subjects Under Fasting Conditions
The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference Product (B): ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe manufactured by Kashiv Biosciences LLC, USA in healthy, adult human subjects. and also to assess safety and tolerability of investigational product.
Read the detailed description
An Open label, Randomized, Balanced, Two-treatment, Single Period, Parallel, Single dose, Subcutaneous administration, comparative pharmacokinetic study of ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector compared to ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe in normal, healthy, adult subjects under fasting conditions.
The total expected study duration of the clinical part is approximately 127 days from the day of check-in to end study visit.
Approximate volume of blood loss in the study will be 150 mL.
Handling of Pharmacokinetic Samples After collection, blood samples will be allowed to clot at room temperature for at least 30 to 60 minutes and then will be placed in a refrigerated centrifuge, and then spun at 3000 rpm (± 50 rpm) under refrigeration at 4° C (±2° C) for 10 minutes. The serum will be divided into two aliquots in such a way that the Aliquots#01 (primary aliquot) will contain at least 1.2 mL of serum and the remaining quantity of serum will be transferred into the Aliquots#02 (secondary aliquot) and will be stored in freezer at -70ºC ± 10ºC at the clinical facility until shipment to the analytical facility.
The time between the end of centrifugation and placement of samples in the Freezer shall not exceed 45 minutes (+ 15 minutes).
The samples will be stored in a freezer at -70ºC ± 10ºC at the analytical facility until analyzed (all the temperature excursions will be handled as per in-house SOP).
In case of any processing error due to any reason (e.g. mixing of sample while segregation, mechanical failure in centrifuge, etc.) during the sample processing, re-spun the sample (s) under the same conditions, if required.
Note:
Transfer of serum samples into the freezer shall take place as soon as possible so the total elapsed time from blood collection to placement of serum samples in the freezer does not exceed 120 minutes.
Statistical analyses will be performed on ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf for Omalizumab using the SAS® software version 9.4 or higher. The pharmacokinetic analysis will include evaluable data from all the subjects who comply with the protocol sufficiently, complete the study and for whom the PK profile can be adequately characterized. The ln-transformed pharmacokinetic parameters e.g. Cmax, AUC0-t and AUC0-∞ will be analyzed using a PROC MIXED effect ANOVA model with the main effect of treatment as fixed effect. A separate ANOVA model will be used to analyze each of the pharmacokinetic parameters. Treatment effects will be tested at the 0.05 level of significance against the residual error (mean square error or MSE) from the ANOVA as the error term. The power of ANOVA test to detect a 20% mean difference between test and reference formulations will be reported. Difference of LSMs will be calculated for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞. The difference will be of the form: Test Product (A) - Reference Product (B). Ratios of means will be expressed in percentage by taking the anti-ln value of difference of LSM. The geometric mean values will be reported. 90% confidence intervals for the difference between investigational product LSMs will be calculated for the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ using ln-transformed data. The confidence intervals will be expressed as a percentage relative to the LSM of the reference product.
Based on the 90% confidence intervals for the difference of means of lntransformed Pharmacokinetic Parameters Cmax, AUC0-t and AUC0-∞ conclusions will be drawn whether the test product is bioequivalent to the reference product.
under fasting condition. The acceptance range for bioequivalence is 80.00-125.00% for the 90% confidence intervals for the difference of means of ln-transformed Cmax, AUC0-t and AUC0-∞ with respect to Omalizumab.
- Conditions
- Healthy Adult Subjects
- Being tested
- ADL-018 Autoinjector, ADL-018 Injection
- Keywords
- Xolair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADL-018 AutoinjectorDevice
Test product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector manufactured/supplied by Kashiv BioSciences LLC, USA.
ADL-018 InjectionDrug
Reference Product (B): ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe manufactured/supplied by Kashiv BioSciences LLC, USA
| Study group | Role | What they receive |
|---|---|---|
| test product | Experimental | Test product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector manufactured/supplied by Kashiv BioSciences LLC, USA. Receives: Device: ADL-018 Autoinjector |
| reference product | Active comparator | Reference Product (B): ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe manufactured/supplied by Kashiv Biosciences LLC, USA Receives: Drug: ADL-018 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter
Cmax
Measured: Baseline to day 126
Pharmacokinetic parameter
AUC0-t
Measured: Baseline to day 126
Pharmacokinetic parameter
AUC0-inf
Measured: baseline to day 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start29 Jan 2025
- Primary completion15 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies 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
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kashiv BioSciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929052
- Sponsor's protocol ID
- ADL-018 Autoinjector
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Balanced, Two-treatment, Single Period, Parallel, Single Dose, Subcutaneous Administration, Comparative Pharmacokinetic Study of ADL-018 Injection 150 mg/mL Solution in a Single Dose Pre-filled Autoinjector Compared to ADL-018 Injection 150mg/mL Solution in a Single Dose Pre-filled Syringe in Normal, Healthy, Adult Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06929052
- Acronym / sponsor ID
- ADL-018 Autoinjector
- Conditions
- Healthy Adult Subjects
- Keywords
- Xolair
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Kashiv BioSciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 15 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.
The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference Product (B): ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe manufactured by Kashiv Biosciences LLC, USA in healthy, adult human subjects. and also to assess safety and tolerability of investigational product.
Detailed description
An Open label, Randomized, Balanced, Two-treatment, Single Period, Parallel, Single dose, Subcutaneous administration, comparative pharmacokinetic study of ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector compared to ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe in normal, healthy, adult subjects under fasting conditions.
The total expected study duration of the clinical part is approximately 127 days from the day of check-in to end study visit.
Approximate volume of blood loss in the study will be 150 mL.
Handling of Pharmacokinetic Samples After collection, blood samples will be allowed to clot at room temperature for at least 30 to 60 minutes and then will be placed in a refrigerated centrifuge, and then spun at 3000 rpm (± 50 rpm) under refrigeration at 4° C (±2° C) for 10 minutes. The serum will be divided into two aliquots in such a way that the Aliquots#01 (primary aliquot) will contain at least 1.2 mL of serum and the remaining quantity of serum will be transferred into the Aliquots#02 (secondary aliquot) and will be stored in freezer at -70ºC ± 10ºC at the clinical facility until shipment to the analytical facility.
The time between the end of centrifugation and placement of samples in the Freezer shall not exceed 45 minutes (+ 15 minutes).
The samples will be stored in a freezer at -70ºC ± 10ºC at the analytical facility until analyzed (all the temperature excursions will be handled as per in-house SOP).
In case of any processing error due to any reason (e.g. mixing of sample while segregation, mechanical failure in centrifuge, etc.) during the sample processing, re-spun the sample (s) under the same conditions, if required.
Note:
Transfer of serum samples into the freezer shall take place as soon as possible so the total elapsed time from blood collection to placement of serum samples in the freezer does not exceed 120 minutes.
Statistical analyses will be performed on ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf for Omalizumab using the SAS® software version 9.4 or higher. The pharmacokinetic analysis will include evaluable data from all the subjects who comply with the protocol sufficiently, complete the study and for whom the PK profile can be adequately characterized. The ln-transformed pharmacokinetic parameters e.g. Cmax, AUC0-t and AUC0-∞ will be analyzed using a PROC MIXED effect ANOVA model with the main effect of treatment as fixed effect. A separate ANOVA model will be used to analyze each of the pharmacokinetic parameters. Treatment effects will be tested at the 0.05 level of significance against the residual error (mean square error or MSE) from the ANOVA as the error term. The power of ANOVA test to detect a 20% mean difference between test and reference formulations will be reported. Difference of LSMs will be calculated for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞. The difference will be of the form: Test Product (A) - Reference Product (B). Ratios of means will be expressed in percentage by taking the anti-ln value of difference of LSM. The geometric mean values will be reported. 90% confidence intervals for the difference between investigational product LSMs will be calculated for the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ using ln-transformed data. The confidence intervals will be expressed as a percentage relative to the LSM of the reference product.
Based on the 90% confidence intervals for the difference of means of lntransformed Pharmacokinetic Parameters Cmax, AUC0-t and AUC0-∞ conclusions will be drawn whether the test product is bioequivalent to the reference product.
under fasting condition. The acceptance range for bioequivalence is 80.00-125.00% for the 90% confidence intervals for the difference of means of ln-transformed Cmax, AUC0-t and AUC0-∞ with respect to Omalizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test product | Experimental | Device: ADL-018 AutoinjectorTest product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector manufactured/supplied by Kashiv BioSciences LLC, USA. |
| reference product | Active comparator | Drug: ADL-018 InjectionReference Product (B): ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe manufactured/supplied by Kashiv Biosciences LLC, USA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age: 18 to 65 years of age, inclusive, at the time of dosing.
- Subject should be having serum total IgE ≤ 100 IU/ml at the time of screening
- Gender: Male and/or non-pregnant, non-lactating female. Female of childbearing potential must have a negative serum pregnancy test performed within 28 days prior to dosing day.
- Male subjects and/or female subject's partner must agree to use acceptable form of contraception which includes vasectomy, or use condoms, or spermicide in addition to female contraception for additional protection against conception from screening until 156 days after administration of the study medication.
- For female of childbearing potential, must agree to use acceptable forms of contraception from screening until 156 days after administration of the
Key exclusion criteria (27 listed)
- History of allergic responses to study drug or other related drugs, or any of its formulation ingredients.
- History of allergic reactions or sensitivity to latex or latex derived products.
- Have significant diseases or clinically significant abnormal findings during screening [medical history, comprehensive physical examination, vital signs, laboratory evaluations and ECG].
- Any disease or condition like diabetes, psychosis or others, which might compromise the hemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- History of helminthic or parasitic infection.
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 |
|---|---|---|
| ADL-018 AutoinjectorTest product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector manufactured/supplied by Kashiv BioSciences LLC, USA. | Device | test product |
| ADL-018 InjectionReference Product (B): ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe manufactured/supplied by Kashiv BioSciences LLC, USA | Drug | reference product |
Primary outcome
Pharmacokinetic parameter
Time frame: Baseline to day 126
Cmax
Pharmacokinetic parameter
Time frame: Baseline to day 126
AUC0-t
Pharmacokinetic parameter
Time frame: baseline to day 126
AUC0-inf
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 20 Feb 2026.
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Healthy Subjects
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.
The record lists no contact. Use the official record to reach the sponsor.
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 ADL-018 Autoinjector and ADL-018 Injection in people with Healthy Adult Subjects, run by Kashiv BioSciences, LLC at 1 site in Canada.
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 16 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 20 Feb 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 Canada. 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?
Pharmacokinetic parameter (time frame: Baseline to day 126). 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?
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 20 Feb 2026.