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Injection intralésionnelle de Ronkyla Plus pour le traitement du lipome superficiel

29 septembre 2026 mis à jour par: Glonova Pharma Co., Ltd

Étude d'évaluation de la sécurité, de l'efficacité et de la pharmacocinétique de l'injection intralésionnelle de Ronkyla Plus pour le traitement du lipome superficiel

This study aims to evaluate the safety, efficacy, and pharmacokinetics of Ronkyla Plus, a combinational drug that forms a hydrogel at the injection site, promising a better experience of lipolysis injection for the treatment of superficial lipoma. The study consists of a Part I dose-escalation study to investigate the drug's maximum tolerated dose (MTD) for this indication and a Part II study for evaluating its relative bioavailability in comparison to an FDA-approved lipolysis injection, Kybella.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Part I is a randomized, double-blind, placebo-controlled, and sequential dose-escalation study. Eligible subjects will receive intralesional injections of Ronkyla Plus or placebo at a volume dependent on the size of their superficial lipoma, up to a maximum of 10 mL per treatment, at 28-day intervals for up to a maximum of 6 treatments. In the first treatment cycle, subjects will stay in hospital for 3 hours after treatment for evaluation of acute safety profile. Subjects will return to the hospital on Day 8 and Day 29 of each treatment cycle for safety profile evaluation.

Part II is an open-label, single-dose, 2-treatment, parallel study to evaluate the relative bioavailability of Ronkyla Plus injection in comparison with that of Kybella injection. Eligible, non-smoking males and females aged 18 to 65 with treatable superficial lipoma or submental fullness will be included in the study. Twenty (20) subjects for each target symptom, in a total of 40 subjects, are planned to be enrolled in the study to achieve at least 16 evaluable subjects in each treatment group. After screening, subjects will be assigned to Ronkyla Plus or Kybella treatment based on their symptoms and undergo a 16-day PK assessment.

For Ronkyla Plus injection, subject will receive a single intralesional treatment at the maximum tolerated dose (MTD) as determined in Part I. For Kybella injection, subject will receive the maximum dose approved for a single treatment (100 mg) in the submental area.

In the PK assessment period, subjects will visit the hospital in the mornings of Day 3 (48.0 h), Day 5 (96.0 h), Day 8 (168.0 h), Day 11 (240.0 h), and Day 15 (336.0 h), and two consecutive 24-hr PK blood samplings from Day -2 evening to Day 2 morning (pre-dose, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0 h post-dose on Day 1~Day 2; same blood sampling time on Day -1~Day 1 without dosing). Two weeks after the end of the 16-day PK assessment period, subjects of Ronkyla Plus cohort will be eligible for up to 5 additional treatments of Ronkyla Plus for complete clearance of their target superficial lipomas, whereas subjects of Kybella cohort will be eligible for up to 5 additional treatments of Ronkyla (10.56 mg/mL SDC injection approved in Taiwan for submental fullness treatment, pharmaceutical equivalent of Kybella) for improvement of their submental fullness.

Type d'étude

Interventionnel

Inscription (Estimé)

56

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Taïwan
    • Da'an District
      • Taipei, Da'an District, Taïwan, 106436
        • Recrutement
        • Cathay General Hospital
        • Contact:
        • Sous-enquêteur:
          • Chi-Ming Pu, MD
    • Sijhih District
      • New Taipei City, Sijhih District, Taïwan, 22174
        • Recrutement
        • Cathay General Hospital Sijhih Branch
        • Contact:
    • Xinyi District
      • Taipei, Xinyi District, Taïwan, 110301
        • Recrutement
        • Taipei Medical University Hospital
        • Contact:
          • Ming-Hsiu Lin, MD, Ph.D.
          • Numéro de téléphone: 8215 +886 2737181
          • E-mail: minghsiu@tmu.edu.tw
        • Chercheur principal:
          • Ming-Hsiu Lin, MD, Ph.D.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Healthy male or female adults aged 18 to 65 years, inclusive.

  2. One or more superficial lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:

    • History of slow growth followed by dormancy, and stable for at least 6 months.
    • Greatest length by greatest perpendicular width between 1 and 10 square centimeters, inclusive.
    • Discrete, oval to rounded in shape, not hard or attached to underlying tissue.
    • Located on the trunk, arms, legs, or neck
    • Needle biopsy core tissue sample histological analysis results consistent with a diagnosis of lipoma.

    OR, sufficient submental fat for injection of 100 mg Kybella in the judgment of the investigator (Part II Kybella cohort only)

  3. Body mass index (BMI): BMI between 22 to 30 (normal, overweight and slight obese).

  4. History of stable body weight, in the judgment of the investigator, for at least 6 months before enrollment.

  5. The health status is assessed by the investigator as "normal healthy" based on required screening assessments.

  6. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before enrollment and agree to use a highly effective method of contraception from enrollment up to the study end, such as:

    • Intrauterine device
    • Combined (estrogen- and progestogen-containing) hormonal contraception associated with the inhibition of ovulation (oral, intravaginal, or transdermal)
    • Progestogen-only hormonal contraception associated with the inhibition of ovulation (oral, injectable, intrauterine, or implantable)
    • Tubal ligation
    • Vasectomized male partner
    • Sexual abstinence

    Female subject being postmenopausal for at least 1 year or surgically sterile is considered to be of no childbearing potential.

  7. Able and willing to comply with scheduled clinic visits and clinical trial procedures.

  8. Capable of understanding and giving signed informed consent form after full discussion of the research nature of the treatment and its risk and benefits with the investigator/ designee of the sponsor.

Exclusion Criteria:

  1. History of surgical treatment for the target superficial lipoma or submental area (Part II Kybella cohort only).

  2. Current infection or wound near the target superficial lipoma or the submental area (Part II Kybella cohort only).

  3. History of diabetes.

  4. Allergic to excipients of Ronkyla Plus or Kybella (Part II Kybella cohort only)

  5. A result on coagulation tests (prothrombin time, activated partial thromboplastin time) obtained within 28 days before enrollment that indicates the presence of any clinically significant bleeding disorder (subjects being treated with antiplatelet therapy or anticoagulants could be enrolled after 7-day washout period):

    • Prothrombin time > 20 seconds.
    • Activated partial thromboplastin time > 60 seconds.
    • INR > 3.

  6. Any ongoing medical condition with significant risk of bleeding

  7. Evidence of any serious active infections, COVID 19, severe uncontrolled cardiac, renal, hepatic, pulmonary or other systemic disease, significant medical or psychiatric condition, known seropositivity to HIV/HBV/HCV, or clinically significant laboratory findings that would, in the investigator's judgment, make the subject inappropriate for the study.

  8. Administration of an investigational drug within 30 days prior to enrollment.

  9. Administration of a COVID-19 vaccine within 30 days prior to enrollment.

  10. Abnormal hepatic and renal functions; hematologic changes at screening:

    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 X upper limit of normal (ULN).
    • Total bilirubin > 1.5 X ULN.
    • Serum creatinine > 1.5 X ULN.
    • Hemoglobin < lower limit of normal (LLN).
    • Platelets ≤ 100.000/mm³.

  11. Current malignancy of any organ system or a history within 5 years.

  12. Subjects who, in the opinion of the investigator, are not likely to complete the trial for whatever reason.

Part I & Part II Ronkyla Plus cohort specific exclusion criteria:

  1. History of any medical condition contraindicated or not recommended for aspirin use including active peptic ulcer disease, asthma, gout, uncontrolled hypertension.
  2. Taking any medication contraindicated or not recommended for concomitant use with aspirin within 7 days prior to enrollment.
  3. Allergic to Aspirin, salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs).
  4. The target lipoma warrants surgical removal per the investigator's judgement (e.g., for confirming its pathology).

Part I dose level 2 and 4 cohorts & Part II specific exclusion criteria:

  1. History of alcohol or drug abuse within the past year prior to Day 1.
  2. History of smoking or use of nicotine-containing product within 6 months prior to Day 1.
  3. Donation or significant loss of blood (480 mL or more) within 60 days prior to Day 1.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Part I: Dose Level 1

0.25 mL/cm2 of Ronkyla Plus (n=3), or placebo in equivalent injection volume/lipoma size (n=1) every 4 weeks for up to 6 treatments.
Médicament: Ronkyla Plus

Ronkyla Plus is a new formulation of sodium deoxycholate lipolysis injection. It forms a hydrogel at the injection site.

Médicament: Placebo

Normal saline for injection.

Autres noms:
  • Solution saline normale
Expérimental: Part I: Dose Level 2

0.5 mL/cm2 of Ronkyla Plus (n=3), or placebo in equivalent injection volume/lipoma size (n=1) every 4 weeks for up to 6 treatments.
Médicament: Ronkyla Plus

Ronkyla Plus is a new formulation of sodium deoxycholate lipolysis injection. It forms a hydrogel at the injection site.

Médicament: Placebo

Normal saline for injection.

Autres noms:
  • Solution saline normale
Expérimental: Part I: Dose Level 3

0.75 mL/cm2 of Ronkyla Plus (n=3), or placebo in equivalent injection volume/lipoma size (n=1) every 4 weeks for up to 6 treatments.
Médicament: Ronkyla Plus

Ronkyla Plus is a new formulation of sodium deoxycholate lipolysis injection. It forms a hydrogel at the injection site.

Médicament: Placebo

Normal saline for injection.

Autres noms:
  • Solution saline normale
Expérimental: Part I: Dose Level 4

1.0 mL/cm2 of Ronkyla Plus (n=3), or placebo in equivalent injection volume/lipoma size (n=1) every 4 weeks for up to 6 treatments.
Médicament: Ronkyla Plus

Ronkyla Plus is a new formulation of sodium deoxycholate lipolysis injection. It forms a hydrogel at the injection site.

Médicament: Placebo

Normal saline for injection.

Autres noms:
  • Solution saline normale
Expérimental: Part II: Ronkyla Plus treatment

Eligible subjects with a treatable superficial lipoma will receive a single treatment of Ronkyla Plus at the maximum tolerated dose determined in Part I and undergo a 16-day PK assessment.
Médicament: Ronkyla Plus

Ronkyla Plus is a new formulation of sodium deoxycholate lipolysis injection. It forms a hydrogel at the injection site.
Comparateur actif: Part II: Kybella treatment

Eligible subjects with submental fullness will receive a single treatment of Kybella at the maximum approved dose for a single session (100 mg) and undergo a 16-day PK assessment.
Médicament: Kybella

10 mg/mL deoxycholic acid injection

Autres noms:
  • ATX-101
  • acide désoxycholique

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Part I: Incidence of all adverse events
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure
7 months (Part I); 1 month (Part II)
Part I: Incidence of all serious adverse events
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure
7 months (Part I); 1 month (Part II)
Part I: Incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2 bone marrow toxicities
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure. CTCAE version 5.0 (Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening, Grade 5: Death)
7 months (Part I); 1 month (Part II)
Part I: Incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2 cardiac toxicities
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure. CTCAE version 5.0 (Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening, Grade 5: Death)
7 months (Part I); 1 month (Part II)
Part I: Change from baseline in vital signs
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure. Measurement of blood pressure (including systolic blood pressure and diastolic blood pressure, unit: mmHg; pulse rate, unit: beats/mins; respiratory rate, unit: times/min; body temperature, unit: degree Celsius)
7 months (Part I); 1 month (Part II)
Part I: Change from baseline in physical and weight measurement
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure. Physical examination includes: general appearance and weight (kg), HEENT (head, eyes, ears, nose, and throat), mouth, skin, neck (including thyroid), lymph nodes, spine, cardiovascular system, gastrointestinal system, nervous system, musculoskeletal system, mental status.
7 months (Part I); 1 month (Part II)
Part I: Change from baseline in Comprehensive Metabolic Panel blood test
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure. Blood test for: albumin, blood urea nitrogen, calcium, carbon dioxide, chloride, creatinine, glucose, potassium, sodium, total bilirubin and protein, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase
7 months (Part I); 1 month (Part II)
Part I: Change from baseline in Complete blood count test
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure. Blood test includes: hemoglobin, hematocrit, red blood cell, white blood cell (neutrophils, band %, segment %, eosinophils, basophils, lymphocytes, and monocytes), platelet count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin
7 months (Part I); 1 month (Part II)
Part I: Change from baseline in lipid profile.
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure. Blood test includes: total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride.
7 months (Part I); 1 month (Part II)
Part I: Change from baseline in thyroid test.
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure. Blood test includes: triidothyronine, thyroxine, and thyroid-stimulating hormone.
7 months (Part I); 1 month (Part II)
Part I: Change from baseline in urinalysis
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure. Measurement includes: pH, protein, occult blood, leukocyte, glucose, ketones, bilirubin, urobilinogen, nitrite, clinical microscopy.
7 months (Part I); 1 month (Part II)
Part I: Change from baseline in inflammation evaluation.
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure. Test includes: c-reactive protein, erythrocyte sedimentation rate
7 months (Part I); 1 month (Part II)
Part I: Change from baseline in coagulation function.
Délai: 7 months (Part I); 1 month (Part II)

Also a Part II Secondary Outcome Measure. Blood test includes: prothrombin time, activated partial thromboplastin time
7 months (Part I); 1 month (Part II)
Part II: Baseline-adjusted area under the plasma concentration-time curve over a 24-hour period (AUC0-24) of deoxycholic acid
Délai: 16 days

PK values on Day -1~Day 1 (pre-dosing) will be subtracted from PK values on Day 1 ~Day 15 (post-dosing)
16 days
Part II: Baseline-adjusted area under the curve from zero to time infinity (AUC0-inf) of deoxycholic acid
Délai: 16 days

PK values on Day -1~Day 1 (pre-dosing) will be subtracted from PK values on Day 1 ~Day 15 (post-dosing)
16 days
Part II: Baseline-adjusted peak plasma concentration (Cmax) of deoxycholic acid
Délai: 16 days

PK values on Day -1~Day 1 (pre-dosing) will be subtracted from PK values on Day 1 ~Day 15 (post-dosing)
16 days
Part II: Baseline-adjusted time to maximum concentration (Tmax) of deoxycholic acid
Délai: 16 days

PK values on Day -1~Day 1 (pre-dosing) will be subtracted from PK values on Day 1 ~Day 15 (post-dosing)
16 days
Part II: Baseline-adjusted elimination half-life (T1/2) of deoxycholic acid
Délai: 16 days

PK values on Day -1~Day 1 (pre-dosing) will be subtracted from PK values on Day 1 ~Day 15 (post-dosing)
16 days
Part II: Baseline-adjusted, dose-normalized area under the plasma concentration-time curve over a 24-hour period (AUC0-24)
Délai: 16 days

Baseline-adjusted PK values will be divided by the injected dose of deoxycholic acid
16 days
Part II: Baseline-adjusted, dose-normalized area under the curve from zero to time infinity (AUC0-inf) of deoxycholic acid
Délai: 16 days

Baseline-adjusted PK values will be divided by the injected dose of deoxycholic acid
16 days
Part II: Baseline-adjusted, dose-normalized peak plasma concentration (Cmax) of deoxycholic acid
Délai: 16 days

Baseline-adjusted PK values will be divided by injected dose of deoxycholic acid
16 days
Part II: Baseline-adjusted, dose-normalized time to maximum concentration (Tmax) of deoxycholic acid
Délai: 16 days

Baseline-adjusted PK values will be divided by the injected dose of deoxycholic acid.
16 days
Part II: Baseline-adjusted, dose-normalized elimination half-life (T1/2) of deoxycholic acid
Délai: 16 days

Baseline-adjusted PK values will be divided by the injected dose of deoxycholic acid
16 days

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of subjects with "complete" or "almost complete" clearance of the target superficial lipoma at the end of Cycle 2 (Part I only)
Délai: 2 months

At screening, 1 target superficial lipoma will be selected for treatment. Lipoma will be measured in ≥ 2 dimensions (longest length, perpendicular width, and height if possible) using both digital calipers and ultrasound imaging.

Almost complete clearance is defined as ≥ 90% reduction in surface area of the target superficial lipoma
2 months
Percentage of subjects with "complete" or "almost complete" clearance of the target superficial lipoma at the end of each treatment cycle and end of study
Délai: 7 months (Part I); 1 month (Part II)

Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort
7 months (Part I); 1 month (Part II)
Percentage of subjects with "complete" clearance of the target superficial lipoma at the end of each treatment cycle and end of study
Délai: 7 months (Part I); 1 month (Part II)

Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort
7 months (Part I); 1 month (Part II)
Percentage of subjects with "almost complete" clearance of the target superficial lipoma at the end of each treatment cycle and end of study
Délai: 7 months (Part I); 1 month (Part II)

Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort
7 months (Part I); 1 month (Part II)
Percentage reduction in size of the target superficial lipoma at the end of each treatment cycle and end of study
Délai: 7 months (Part I); 1 month (Part II)

Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort
7 months (Part I); 1 month (Part II)
Percentage of subjects having their target superficial lipoma rated by the investigator as 0 or 1 point on the investigator's lipoma morphology assessment scale at the end of each treatment cycle and end of study
Délai: 7 months (Part I); 1 month (Part II)

Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort.

At screening, the beginning/end of each treatment cycle, and the end of study, the investigator will use a 4-point scale of 0-3 to rate the morphology of subjects' target lipomas where 0= Not palpable, 1=Not visible, barely palpable, 2=Visible upon palpation, and 3=Clearly visible, easily palpable. A score of 0 to 1 indicates favorable morphological changes of the target lipoma following treatment(s).
7 months (Part I); 1 month (Part II)
Percentage of subjects having their target superficial lipoma rated by the investigator with ≥2 points improvement on the investigator's lipoma morphology assessment scale at the end of each treatment cycle and end of study
Délai: 7 months (Part I); 1 month (Part II)

Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort. Investigator's lipoma morphology assessment scale where 0 = not palpable; 1 = not visible, barely palpable; 2 = visible upon palpation; 3 = clearly visible, easily palpable. The percentage of subjects having their target superficial lipomas assessed by the investigator on the scale as follows: 0 or 1 point; with ≥ 2 points improvement from baseline; with ≥ 1 point improvement from baseline.
7 months (Part I); 1 month (Part II)
Percentage of subjects having their target superficial lipoma rated by the investigator with ≥1 point improvement on the investigator's lipoma morphology assessment scale at the end of each treatment cycle and end of study
Délai: 7 months (Part I); 1 month (Part II)

Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort. Investigator's lipoma morphology assessment scale where 0 = not palpable; 1 = not visible, barely palpable; 2 = visible upon palpation; 3 = clearly visible, easily palpable. The percentage of subjects having their target superficial lipomas assessed by the investigator on the scale as follows: 0 or 1 point; with ≥ 2 points improvement from baseline; with ≥ 1 point improvement from baseline.
7 months (Part I); 1 month (Part II)
Percentage of subjects being satisfied with treatment outcome at the end of each treatment cycle and end of study
Délai: 7 months (Part I); 1 month (Part II)

Days 29, 57, 85, 113, 141, 169, 197 for Part I; Day 29 for Part II Ronkyla Plus cohort.

Satisfaction assessment will be performed independently by subjects using a 5-point scale where 0 = worsen, 1 = no response, 2 = moderate response, 3 = good response, and 4 = excellent response. A score of 3 or 4 qualifies for a satisfactory treatment outcome.
7 months (Part I); 1 month (Part II)
Injection site pain rated by subjects on a 0-10 numeric rating scale (NRS) at 1 hour and 1 week after each treatment
Délai: 25 weeks (Part I); 1 week (Part II)

Days 1, 8, 29, 36, 57, 64, 85, 92, 113, 120, 141, 148 for Part I; Days 1, 8 for Part II Ronkyla Plus cohort.

At approximately 1 hour after each treatment, and at the 1-week follow-up visit for each treatment, subjects will be asked to rate their injection site pain using a 0-10 numeric rating scale (NRS) where 0 = no pain and 10 = most severe pain possible.
25 weeks (Part I); 1 week (Part II)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Glonova Pharma Co., Ltd

Collaborateurs

T-TOP Clinical Research Co., Ltd.

Les enquêteurs

  • Chercheur principal: Yu-Hsiu Yen, MD, Cathay General Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 novembre 2025

Achèvement primaire (Estimé)

31 mai 2028

Achèvement de l'étude (Estimé)

31 août 2028

Dates d'inscription aux études

Première soumission

13 novembre 2025

Première soumission répondant aux critères de contrôle qualité

16 novembre 2025

Première publication (Réel)

19 novembre 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SDC003

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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