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表在性脂肪腫の治療のための病変内ロンキラプラス注射

2026年9月29日 更新者：Glonova Pharma Co., Ltd

表在性脂肪腫の治療のための病変内ロンキラプラス注射の安全性、有効性及び薬物動態評価試験

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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

56

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 台湾
    • Da'an District
      • Taipei、Da'an District、台湾、106436
        • 募集
        • Cathay General Hospital
        • コンタクト：
        • 副調査官：
          • Chi-Ming Pu, MD
    • Sijhih District
      • New Taipei City、Sijhih District、台湾、22174
        • 募集
        • Cathay General Hospital Sijhih Branch
        • コンタクト：
    • Xinyi District
      • Taipei、Xinyi District、台湾、110301
        • 募集
        • Taipei Medical University Hospital
        • コンタクト：
        • 主任研究者：
          • Ming-Hsiu Lin, MD, Ph.D.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：順次割り当て
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：Ronkyla Plus

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

薬：Placebo

Normal saline for injection.

他の名前：
  • 生理食塩水
実験的：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.
薬：Ronkyla Plus

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

薬：Placebo

Normal saline for injection.

他の名前：
  • 生理食塩水
実験的：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.
薬：Ronkyla Plus

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

薬：Placebo

Normal saline for injection.

他の名前：
  • 生理食塩水
実験的：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.
薬：Ronkyla Plus

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

薬：Placebo

Normal saline for injection.

他の名前：
  • 生理食塩水
実験的：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.
薬：Ronkyla Plus

Ronkyla Plus is a new formulation of sodium deoxycholate lipolysis injection. It forms a hydrogel at the injection site.
アクティブコンパレータ：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.
薬：Kybella

10 mg/mL deoxycholic acid injection

他の名前：
  • ATX-101
  • デオキシコール酸

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Part I: Incidence of all adverse events
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：16 days

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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of subjects with "complete" or "almost complete" clearance of the target superficial lipoma at the end of Cycle 2 (Part I only)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Glonova Pharma Co., Ltd

協力者

T-TOP Clinical Research Co., Ltd.

捜査官

  • 主任研究者：Yu-Hsiu Yen, MD、Cathay General Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年11月14日

一次修了 (推定)

2028年5月31日

研究の完了 (推定)

2028年8月31日

試験登録日

最初に提出

2025年11月13日

QC基準を満たした最初の提出物

2025年11月16日

最初の投稿 (実際)

2025年11月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月2日

QC基準を満たした最後の更新が送信されました

2026年9月29日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • SDC003

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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