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Mild to Moderate Atopic DermatitisPhase 1NCT05729074

A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients

A Phase 1 study of Mild to Moderate Atopic Dermatitis, run by HK inno.N Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the safety, tolerability and pharmacokinetic properties of IN-A002 Ointment in healthy adult male volunteers and mild to moderate atopic dermatitis patients Read more about this study

Who is it for?
Ages 19 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Mild to Moderate Atopic Dermatitis
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
1 siteSouth Korea
Study dates
13 Feb 2023to 20 Sep 2024
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 19 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adult male volunteers aged 19 years or older when the informed consent is obtained.
  • Those whose body weight is above 50.0 kg, with body mass index (BMI) BMI ≥ 18.0 and ≤ 30.0 kg/m2 at screening.
  • Those who have no skin disorder or damage (including scars, tattoos, heavy freckle) that may affect the absorption of investigational product, or have no heavy hair in the drug application area.
  • Those who have no congenital or chronic disease, or pathological symptoms or findings in the result of medical examination.
  • Those who are judged eligible for this study upon judgment of the investigator in screening tests established depending on the characteristics of investigational product (examinations by interview, clinical laboratory test, vital signs, physical examinations, 12-lead electrocardiogram (ECG)).
  • Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening procedure.
Show all 14Show fewer
  • Adult male volunteers aged ≥ 19 years and ≤ 65 years when the informed consent is obtained.
  • BMI ≥ 18.0 and ≤ 30.0 kg/m2 at screening.
  • Subjects who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening procedure.
  • Confirmed diagnosis of AD according the criteria of Hanifin and Rajka (1980).
  • AD lesions that can be applied by investigational product, with a minimum of 5% to a maximum of 30% BSA involvement at screening.
  • AD diagnosed by EASI score of mild (EASI < 16) or moderate (16 ≤ EASI < 23) at screening.
  • Blood vessels whose blood sample collection may be available for PK analysis.
  • Subjects who are judged eligible for this study upon judgment of the investigator in screening tests established depending on the characteristics of investigational product (examinations by interview, clinical laboratory test, vital signs, physical examinations, 12-lead ECG).

Who cannot join

  • Subjects who have the following prior/current history in addition to experience or history of clinically significant hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematological, malignancy, urogenital, cardiovascular, digestive, or musculoskeletal disease:
  • ① Atopic dermatitis ② Psoriasis ③ Eczema ④ Contact dermatitis ⑤Thrombocytopenia ⑥ Anemia ⑦ Neutropenia ⑧ Latent or active tuberculosis
  • Subjects who have history of hypersensitivity (e.g., anaphylactic reaction or angioedema) to the drugs, including Janus kinase inhibitors and excipients, and other drugs (aspirin, penicillin antibiotics, macrolide antibiotics), or subjects who have history of clinically significant hypersensitivity.
  • Suspected acute viral or bacterial infection within 2 weeks prior to the expected initial application date, or fever (body temperature in the tympanic membrane ≥ 38.0ºC) at the time of screening.
  • The following clinically significant findings on 12-lead ECG at screening:
  • QTc > 450 ms
Show all 67Show fewer
  • PR interval > 200 ms
  • QRS duration > 120 ms
  • Any of the following abnormalities in clinical laboratory tests at screening:
  • Blood count (platelet or ANC level < 0.5 x lower limit of normal);
  • Liver function test (AST, ALT, ALP, γ-GTP, or total bilirubin level is ≥ 2 x upper limit of normal);
  • Serum creatinine level that is outside the reference range, or an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 as determined by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Equation;
  • Positive anti-HCV, HBs Ag, HIV Ag/Ab, Syphilis-RPR, or IGRA test.
  • Subjects who received live vaccines within 3 months prior to the expected initial application date, or subjects who have a plan to receive live vaccines over a period from the informed consent to post-study visit (PSV).
  • Subjects who have history of drug abuse, or who have a positive urine test for drugs of abuse.
  • Subjects who have shown the following vital signs at screening when measured after at least 3-min rest:
  • Sitting systolic blood pressure ≥ 150 mmHg or ≤ 90 mmHg.
  • Sitting diastolic blood pressure ≥ 100 mmHg or ≤ 60 mmHg.
  • Sitting pulse rate ≤ 40 bpm or ≥ 100 bpm.
  • Subjects who cannot continuously abstain from sunbath or artificial suntan over a period from 2 weeks prior to the expected initial application date to PSV.
  • Subjects who have taken prescription drugs or oriental medicines that may affect the characteristics of investigational product within 2 weeks prior to the expected initial application date, or subjects who have taken OTC drugs or vitamin preparations within 10 days prior to the expected initial application date, or subjects who are expected to take the above drugs over a period from the informed consent to PSV (however, if the drug is judged not to affect the evaluation of investigational product by the investigator, the subject may participate in the clinical trial.).
  • Subjects who have taken any drugs known to significantly induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 1 month prior to the expected initial application date.
  • Subjects who have participated in other clinical trials within 6 months prior to the expected initial application date (however, for the completion date of other clinical trials, the next date is calculated as 1 day on the basis of the last application date.).
  • Subjects who have donated whole blood within 2 months prior to the expected initial application date or apheresis within 1 month, or received blood transfusion within 1 month prior to the expected initial application date, or subjects who cannot continuously abstain from blood donation over a period from the informed consent to PSV.
  • Subjects who have history of regular alcohol consumption exceeding 21 units/week (1 unit = 10 g = 12.5 mL of pure alcohol) within 6 months prior to the expected initial application date, or subjects who cannot continuously abstain from alcohol consumption over a period from the informed consent to PSV.
  • ☞The amount of alcohol (g) = alcohol consumption (mL) x alcohol content (%) x 0.8
  • Subjects who have history of average use of 10 cigarettes daily within 3 months prior to the expected initial application date, and subjects who cannot cease smoking over a period from 24 hours prior to the expected initial application date to the last blood sampling point.
  • Subjects who consumed grapefruit-containing food from 48 hours prior to the expected initial application date to PSV, or subjects who cannot avoid taking grapefruit-containing food during this period.
  • Subjects who consumed caffeine-containing food (coffee, green tea, black tea, carbonated beverage, coffee-flavored milk, tonics, etc.) from 24 hours prior to the expected initial application date to the last blood sampling point, or subjects who cannot avoid drinking caffeine-containing food during this period.
  • Subjects participating in regular strenuous exercise greater than daily physical activity from 48 hours prior to the expected initial application date to PSV, or subjects who cannot abstain from strenuous exercise during this period.
  • Subjects or spouses (or partners) who have a plan for pregnancy or although unplanned pregnancy, are unable to use a highly effective method of contraception (e.g., use/implant of hormonal contraceptive or correctly placed intrauterine device, sterilization surgery (vasectomy, tubal ligation, etc.), barrier method (spermicide and condom, a concomitant use of contraceptive diaphragm, vaginal sponge or cervical cap)), over a period from the informed consent to 90 days after the last dose of investigational product.
  • Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.
  • [Part B] 1b Study
  • Subjects who have the following prior/current history in addition to evidence or history of clinically significant skin disorders other than AD (however, the patients with skin disorders that may not affect the AD treatment), hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematological, malignancy, urogenital, cardiovascular, digestive, or musculoskeletal disease:
  • ① Thrombocytopenia ② Anemia ③ Neutropenia ④ Erythroderma ⑤ Latent or active tuberculosis
  • Clinically significant systemic or topical skin infection at screening.
  • Subjects who have taken systemic corticosteroids or immunosuppressive agents that can affect AD-related signs and symptoms within 4 weeks prior to the expected initial application date; subjects who have taken systemic anti-inflammatory or immunomodulatory drugs and systemic antibiotics that can affect AD-related signs and symptoms within 2 weeks prior to the expected initial application date; subjects who have received an UV light therapy to mitigate AD-related symptoms; subjects who are expected to take the above drugs or therapy within the study duration (however, the subject taking a corticosteroid inhaler or nasal spray with a stable dose for at least 3 months may participate in the clinical trial).
  • Treatment with oral antihistamines or topical drugs (topical corticosteroid or calcineurin inhibitor, topical antihistamine, topical antimicrobial medication) that can affect AD-related signs and symptoms prior to the expected initial application date or within 5 life-lives, or subjects who are expected to take the above drugs within the study duration (however, the subject taking a nasal antihistamine spray for the treatment of allergic rhinitis may participate in the clinical trial).
  • Subjects whose hair in the drug application site may be unavailable from 2 weeks prior to the expected initial application date to PSV.
  • Subjects who have history of hypersensitivity (e.g., anaphylactic reaction or angioedema) to the drugs, including Janus kinase inhibitors and excipients, and other drugs (aspirin, penicillin antibiotics, macrolide antibiotics), or subjects who have history of clinically significant hypersensitivity.
  • Suspected acute viral or bacterial infection within 2 weeks prior to the expected initial application date, or fever (body temperature in the tympanic membrane ≥ 38.0ºC) at the time of screening.
  • The following clinically significant findings on 12-lead ECG at screening:
  • QTc > 450 ms
  • PR interval > 200 ms
  • QRS duration > 120 ms
  • Any of the following abnormalities in clinical laboratory tests at the the time of screening:
  • Platelet or ANC level < 0.5 x lower limit of normal;
  • AST, ALT, ALP, γ-GTP, or total bilirubin level is ≥ 2 x upper limit of normal;
  • Serum creatinine level that is outside the reference range, or an eGFR < 60 mL/min/1.73m2 as determined by the CKD-EPI Equation;
  • Positive anti-HCV, HBs Ag, HIV Ag/Ab, Syphilis-RPR, or IGRA test.
  • Subjects who received live vaccines within 3 months prior to the expected initial application date, or subjects who have a plan to receive live vaccines over a period from the informed consent to PSV.
  • Subjects who have history of drug abuse, or who have a positive urine test for drugs of abuse.
  • Subjects who have shown the following vital signs at screening when measured after at least 3-min rest:
  • Sitting systolic blood pressure ≥ 150 mmHg or ≤ 90 mmHg.
  • Sitting diastolic blood pressure ≥ 100 mmHg or ≤ 60 mmHg.
  • Sitting pulse rate ≤ 40 bpm or ≥ 100 bpm.
  • Subjects who have taken prescription drugs or oriental medicines that may affect the characteristics of investigational product within 2 weeks prior to the expected initial application date, or subjects who have taken OTC drugs or vitamin preparations within 10 days prior to the expected initial application date, or subjects who are expected to take the above drugs over a period from the informed consent to PSV (however, if the drug is judged not to affect the PK profile of investigational product by the investigator, the subject may participate in the clinical trial.).
  • Subjects who have participated in other clinical trials within 6 months prior to the expected initial application date (however, for the completion date of other clinical trials, the next date is calculated as 1 day on the basis of the last application date.).
  • Subjects who have donated whole blood within 2 months prior to the expected initial application date or apheresis within 1 month, or received blood transfusion within 1 month prior to the expected initial application date, or subjects who cannot continuously abstain from blood donation over a period from the informed consent to PSV.
  • Subjects who have history of regular alcohol consumption exceeding 21 units/week (1 unit = 10 g = 12.5 mL of pure alcohol) within 6 months prior to the expected initial application date, or subjects who cannot continuously abstain from alcohol consumption over a period from the informed consent to PSV.
  • ☞The amount of alcohol (g) = alcohol consumption (mL) x alcohol content (%) x 0.8
  • Subjects who have history of average use of 10 cigarettes daily within 3 months prior to the expected initial application date, and subjects who cannot cease smoking over a period from 24 hours prior to the expected initial application date to the last blood sampling point.
  • Subjects who consumed grapefruit-containing food from 48 hours prior to the expected initial application date to PSV, or subjects who cannot avoid taking grapefruit-containing food during this period.
  • Subjects who consumed caffeine-containing food (coffee, green tea, black tea, carbonated beverage, coffee-flavored milk, tonics, etc.) from 24 hours prior to the expected initial application date to the last blood sampling point, or subjects who cannot avoid drinking caffeine-containing food during this period.
  • Subjects participating in regular strenuous exercise greater than daily physical activity from 48 hours prior to the expected initial application date to PSV, or subjects who cannot abstain from strenuous exercise during this period.
  • Subjects or spouses (or partners) who have a plan for pregnancy or although unplanned pregnancy, are unable to use a highly effective method of contraception (e.g., use/implant of hormonal contraceptive or correctly placed intrauterine device, sterilization surgery (vasectomy, tubal ligation, etc.), barrier method (spermicide and condom, a concomitant use of contraceptive diaphragm, vaginal sponge or cervical cap)), over a period from the informed consent to 90 days after the last dose of investigational product.
  • Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

Other trials in South Korea

About this study

Official title: A Randomized, Placebo/Active Controlled, Single/Multiple Dosing, Dose Escalation Clinical Phase 1a/b Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients

This study aims to evaluate the safety, tolerability and pharmacokinetic properties of IN-A002 Ointment in healthy adult male volunteers and mild to moderate atopic dermatitis patients

Read the detailed description

Part A: Phase 1a Study

  • Primary objective
  • To evaluate the safety and tolerability after single/multiple dosing of topical IN-A002 Ointment in healthy adult male volunteers.
  • Secondary objective - To evaluate the pharmacokinetic (PK) profile after single/multiple dosing of topical IN-A002 Ointment in healthy adult male volunteers

Part B: Phase 1b Study

  • Primary objective
  • To evaluate the safety and tolerability after multiple dosing of topical IN-A002 Ointment in patients with mild to moderate atopic dermatitis.
  • Secondary objectives
  • To evaluate the PK profile after multiple dosing of topical IN-A002 Ointment in patients with mild to moderate atopic dermatitis.
  • To evaluate the efficacy after multiple dosing of topical IN-A002 Ointment in patients with mild to moderate atopic dermatitis.
Being tested
IN-A002 Ointment 0.3% or IN-A002 Placebo Ointment, IN-A002 Ointment 0.5% or IN-A002 Placebo Ointment, IN-A002 Ointment 1% or IN-A002 Placebo Ointment, IN-A002 Ointment 3% or IN-A002 Placebo Ointment, IN-A002 Ointment 5% or IN-A002 Placebo Ointment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IN-A002 Ointment 0.3% or IN-A002 Placebo OintmentDrug

    Drug: IN-A002 Ointment 0.3%, 10 g/1000 cm2 Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2

  • IN-A002 Ointment 0.5% or IN-A002 Placebo OintmentDrug

    Drug: IN-A002 Ointment 0.5%, 10 g/1000 cm2, for 1 day Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2, for 1 day

  • IN-A002 Ointment 1% or IN-A002 Placebo OintmentDrug

    Drug: IN-A002 Ointment 1%, 10 g/1000 cm2 Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2

  • IN-A002 Ointment 3% or IN-A002 Placebo OintmentDrug

    Drug: IN-A002 Ointment 3%, 10 g/1000 cm2 Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2

  • IN-A002 Ointment 5% or IN-A002 Placebo OintmentDrug

    Drug: IN-A002 Ointment 5%, 10 g/1000 cm2 Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2

  • IN-A002 Ointment 1%Drug

    Drug: IN-A002 Ointment 1%, 3 g/1000 cm2

  • IN-A002 Ointment 3%Drug

    Drug: IN-A002 Ointment 3%, 3 g/1000 cm2

  • Elidel Cream 1% (pimecrolimus)Drug

    Drug: Elidel Cream 1% (pimecrolimus), 3 g/1000 cm2

Study groups in NCT05729074
Study groupRoleWhat they receive
Part A-1(SAD1)ExperimentalIN-A002 Ointment 0.3% or Placebo Ointment, single dose
Receives: Drug: IN-A002 Ointment 0.3% or IN-A002 Placebo Ointment
Part A-1(SAD2)ExperimentalIN-A002 Ointment 0.5% or Placebo Ointment, single dose
Receives: Drug: IN-A002 Ointment 0.5% or IN-A002 Placebo Ointment
Part A-1(SAD3)ExperimentalIN-A002 Ointment 1% or Placebo Ointment, single dose
Receives: Drug: IN-A002 Ointment 1% or IN-A002 Placebo Ointment
Part A-1(SAD4)ExperimentalIN-A002 Ointment 3% or Placebo Ointment, single dose
Receives: Drug: IN-A002 Ointment 3% or IN-A002 Placebo Ointment
Part A-1(SAD5)ExperimentalIN-A002 Ointment 5% or Placebo Ointment, single dose
Receives: Drug: IN-A002 Ointment 5% or IN-A002 Placebo Ointment
Part A-2(MAD1)ExperimentalIN-A002 Ointment 1% or Placebo Ointment, Twice daily (BID), multiple topical applications for 14 days
Receives: Drug: IN-A002 Ointment 1% or IN-A002 Placebo Ointment
Part A-2(MAD2)ExperimentalIN-A002 Ointment 3% or Placebo Ointment, Twice daily (BID), multiple topical applications for 14 days
Receives: Drug: IN-A002 Ointment 3% or IN-A002 Placebo Ointment
Part A-2(MAD3)ExperimentalIN-A002 Ointment 5% or Placebo Ointment, Twice daily (BID), multiple topical applications for 14 days
Receives: Drug: IN-A002 Ointment 5% or IN-A002 Placebo Ointment
Part B(MAD1)ExperimentalIN-A002 Ointment 1%, Twice daily (BID), multiple topical applications for 28 days
Receives: Drug: IN-A002 Ointment 1%
Part B(MAD2)ExperimentalIN-A002 Ointment 3%, Twice daily (BID), multiple topical applications for 28 days
Receives: Drug: IN-A002 Ointment 3%
Part BActive comparatorPart B(MAD1), (MAD2): Elidel Cream 1% (pimecrolimus), Twice daily (BID), multiple topical applications for 28 days
Receives: Drug: Elidel Cream 1% (pimecrolimus)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse event

    For all adverse events collected during the study, the investigator will evaluate serious adverse events, severity, or drug relationship.

    Measured: Up to post study visit (Day 40)

  2. Physical examination

    Physical examination results will be classified as normal, not clinically significant, or clinically significant upon a judgment of the investigator after single/multiple dosing of topical IN-A002 Ointment.

    Measured: Up to post study visit (Day 40)

  3. Clinical Laboratory Test

    Clinical laboratory test, the results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of topical IN-A002 Ointment.

    Measured: Up to post study visit (Day 40)

  4. Topical Reaction Assessment

    The numerical scores on the findings of skin reactions (erythema, papule, edema, bulla, blister) after single/multiple dosing of topical IN-A002 Ointment.

    Measured: Predose(0h) at Day 1, Day 8, Day 15, and Day 22, Post-dose(0.5h) at Day 1, Day 8, Day 15, and Day 22, Day 28, Day 29(0h, 0.5h), PSV

  5. NRS (Numerical Pain Rating Scale)

    Each subject will subjectively evaluate the skin irritation intensity (pain) from the range of 1-10 using 'Numerical Rating Score (NRS)'.

    Measured: Predose(0h) at Day 1, Day 8, Day 15, and Day 22, Post-dose(0.5h) at Day 1, Day 8, Day 15, and Day 22, Day 28, Day 29(0h, 0.5h), PSV

  6. EASI score

    Changes in EASI score from the baseline after treatment

    Measured: Day 1, Day 8, Day 15, Day 22, Day 29

  7. IGA score

    Investigator Global Assessment (IGA) Changes in IGA score from the baseline after treatment

    Measured: Day 1, Day 8, Day 15, Day 22, Day 29

  8. Itch Questionnaire

    Changes in Itch Questionnaire from the baseline after treatment

    • NRS for Pruritus
    • NRS for Sleep Disturbance
    • Duration of Itching

    Measured: Day 1, Day 8, Day 15, Day 22, Day 29

  9. Dermatology Life Quality Index (DLQI)

    The DLQI is a 10-question questionnaire used to measure the impact of Atopic Dermatitis(AD) on the quality of life of an AD-affected person for the last week

    Measured: Day 1, Day 8, Day 15, Day 22, Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2023
  2. Study start13 Feb 2023
  3. Primary completion20 Sep 2024
  4. Study completion20 Sep 2024

Resources

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
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05729074
Sponsor's protocol ID
IN_JSI_105
Status last verified
Mar 2025
First submitted
25 Jan 2023
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Mild to Moderate Atopic Dermatitis, run by HK inno.N Corporation at 1 site in South Korea.

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 14 inclusion and 67 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 14 Sep 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 South Korea. 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?

Adverse event (time frame: Up to post study visit (Day 40)). The study lists 9 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 NCT05729074.

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 14 Sep 2026.

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