Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture
2026년 6월 10일 업데이트: CONNEXT
A Phase 1/2, Multicenter, Dose Escalating, Dose Expanding, Adaptive Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of Collagenase CNT201 in Adult Participants With Dupuytren's Contracture
This trial is a multicenter, Phase 1/2, study to assess the safety, tolerability, efficacy, PK, and immunogenicity of CNT201 in adult participants with DC (Dupuytren's Contracture).
연구 개요
상태
모병
상세 설명
This is an adaptive clinical study design containing 2 steps:
- Step 1 (dose escalation) is an open-label, dose escalating design where each participant will be enrolled into 1 of 4 dose levels and receive a single administration of CNT201. A Safety Review Committee (SRC) will decide on the dose escalation steps and which dose(s) will be selected to progress into Step 2 dose expansion stage.
- Step 2 (dose expansion) adopts a randomized, double-blind, placebo-controlled study design. Eligible participants will be randomized to receive either CNT201 or a placebo for up to a total of 3 treatment cycles per cord at the discretion of the Investigator.
연구 유형
중재적
등록 (추정된)
60
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Suntae Kim
- 전화번호: +82-10-5682-2489
- 이메일: suntae.kim@connext.co.kr
연구 장소
-
-
Queensland
-
Kippa-Ring, Queensland, 호주, 4021
- 모병
- A R Houston Medical Pty Ltd.
-
연락하다:
- Anthony R Houston, MD
-
수석 연구원:
- Anthony R Houston, MD
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Men and women, 18 to 75 years of age, inclusive.
- Participants with a diagnosis of DC, with a fixed flexion deformity of at least 1 finger, other than the thumb, that have a contracture at least 20°, but not greater than 100°, for MP (not greater than 80° for PIP) joints, caused by a palpable cord.
- Participants who have a positive Table Top Test, defined as the inability to simultaneously place the affected finger(s) and palm flat against a tabletop.
- Participants who are naive to CNT201 treatment.
- Participants who are judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile.
- Participants who are willing to voluntarily sign and date the Informed Consent Form (ICF) approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
Exclusion Criteria:
- Participants previously exposed to collagenase Clostridium histolyticum for treatment of Dupuytren's disease (Xiaflex, Xiapex®).
- Participants who have received other treatments for advanced Dupuytren's disease, including surgery (fasciectomy or fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study treatment.
- Participants with a chronic muscular, neurological, or neuromuscular disorder that affects the hands, or other medical condition which in the Investigator's opinion will make the participant unsuitable for enrollment in the study.
- Participants who have a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition (eg, testing positive for tuberculosis [TB] or Coronavirus disease 2019 [COVID-19], etc), or history of alcoholism or drug abuse, which in the Investigator's opinion, would make the participant unsuitable for enrollment in the study.
- Participants who have a known allergic response to collagenase or any other excipient of CNT201 or Xiaflex.
- Participants who have received a doxycycline or tetracycline derivative within 14 days before the beginning of the study (tetracycline derivatives may inhibit the collagenolytic activity of mammalian collagenase homologs).
- Participants who have received an anticoagulant (except aspirin ≤150 mg/day) within 7 days before the start of the study.
- Female participants who are nursing or pregnant, or plan to become pregnant during the study treatment stage of the study.
- Participants who have been treated with any investigational drug within 30 days of first dose of study treatment.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: [Step1] CNT201 First-dose
|
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): First-dose |
|
실험적: [Step1] CNT201 Low-dose
|
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): Low-dose |
|
실험적: [Step1] CNT201 Intermediate-dose
|
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): Intermediate-dose |
|
실험적: [Step1] CNT201 High-dose
|
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): High-dose |
|
실험적: [Step2] CNT201
|
eligible participants will be randomized to 1 of 2 or more treatment arms, depending on the number of CNT201 doses selected for administration in Step 2
|
|
위약 비교기: [Step2] Placebo
|
• Saline
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
[Step 1] Incidence of adverse events
기간: Day 1 through Day 57
|
Adverse events including TEAEs, SAEs, and AESIs assessed by frequency and severity, coded using MedDRA and graded per CTCAE v5.0.
All adverse event types will be aggregated and reported as overall incidence of adverse events.
|
Day 1 through Day 57
|
|
[Step 1] Change from baseline in systolic and diastolic blood pressure
기간: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
Systolic and diastolic blood pressure will be measured in mmHg, and the change from baseline will be evaluated at each scheduled visit.
|
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
|
[Step 1] Change from baseline in pulse rate
기간: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
Pulse rate will be measured in beats per minute (bpm), and the change from baseline will be assessed at each scheduled visit.
|
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
|
[Step 1] Change from baseline in respiratory rate
기간: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
Respiratory rate will be measured in breaths per minute, and the change from baseline will be evaluated at each scheduled visit.
|
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
|
[Step 1] Change from baseline in body temperature
기간: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
Body temperature will be measured in degrees Celsius (°C), and the change from baseline will be evaluated at each scheduled visit.
|
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
|
|
[Step 1] Change from baseline in 12-lead ECG parameters
기간: Screening and Day 1 (1 hour post-dose)
|
Electrocardiogram (ECG) parameters including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval using Fridericia's formula (QTcF) will be assessed using automated 12-lead ECG recordings.
|
Screening and Day 1 (1 hour post-dose)
|
|
[Step 1] Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
기간: Screening and Day 57
|
Clinical laboratory assessments include hematology, clinical chemistry, coagulation, and urinalysis parameters.
The number of participants with clinically significant changes from baseline will be summarized.
|
Screening and Day 57
|
|
[Step 1] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
기간: Screening, Day 1 (pre-dose), Day29, and Day 57
|
Complete physical examinations were performed at scheduled visits.
Clinically significant abnormalities, including injection site reactions, were recorded and summarized as the number of participants with abnormalities.
|
Screening, Day 1 (pre-dose), Day29, and Day 57
|
|
[Step 1] Proportion of participants achieving reduction in contracture to within 0-5° of normal extension
기간: Within 29 days of study treatment injection
|
Finger joint contracture (MP and PIP joints) measured by goniometry.
|
Within 29 days of study treatment injection
|
|
[Step 2] Incidence of TEAEs, SAEs, and AESIs by severity
기간: Screening through Month 12
|
Frequency and severity of adverse events coded using MedDRA and graded per CTCAE v5.0.
|
Screening through Month 12
|
|
[Step 2] Change from baseline in systolic and diastolic blood pressure
기간: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
Systolic and diastolic blood pressure will be measured in mmHg, and the change from baseline will be evaluated at each scheduled visit.
|
Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Change from baseline in pulse rate
기간: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
Pulse rate will be measured in beats per minute (bpm), and the change from baseline will be assessed at each scheduled visit.
|
Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] ] Change from baseline in respiratory rate
기간: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
Respiratory rate will be measured in breaths per minute, and the change from baseline will be evaluated at each scheduled visit.
|
Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Change from baseline in body temperature
기간: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
Body temperature will be measured in degrees Celsius (°C), and the change from baseline will be evaluated at each scheduled visit.
|
Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Change from Baseline in Electrocardiogram Parameters
기간: Screening and Day 1 (1 hour post-dose) of each cycle (each cycle is 28 days)
|
Electrocardiogram (ECG) parameters including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval using Fridericia's formula (QTcF) will be assessed using automated 12-lead ECG recordings.
|
Screening and Day 1 (1 hour post-dose) of each cycle (each cycle is 28 days)
|
|
[Step 2] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
기간: Screening, Day 1 of each injection cycle (pre-dose), Day 29 of each cycle and Month 12 (each cycle is 28 days)
|
Complete physical examinations were performed at scheduled visits.
Clinically significant abnormalities, including injection site reactions, were recorded and summarized as the number of participants with abnormalities.
|
Screening, Day 1 of each injection cycle (pre-dose), Day 29 of each cycle and Month 12 (each cycle is 28 days)
|
|
[Step 2] Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
기간: Screening through Week 52
|
Clinical laboratory assessments include hematology, clinical chemistry, coagulation, and urinalysis parameters.
The number of participants with clinically significant changes from baseline will be summarized.
|
Screening through Week 52
|
|
[Step 2] Proportion of participants achieving reduction in contracture to within 0-5° of normal extension within 29 days after the first injection
기간: Within 29 days after first injection
|
Finger joint contracture (MP and PIP joints) measured by goniometry.
|
Within 29 days after first injection
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
[Step 1] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
기간: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
Assessed by finger goniometry at each scheduled visit.
|
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
|
[Step 1] Mean percent change in degree of contracture
기간: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
Assessed by finger goniometry (MP and PIP joints).
|
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
|
[Step 1] Time to clinical success (contracture ≤5°)
기간: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
Defined as the first study day on which treated joint contracture is ≤5°.
|
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
|
[Step 1] Change in range of motion (full extension, full flexion, and total arc)
기간: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
Assessed by finger goniometry (MP and PIP joints).
|
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
|
|
[Step 1] Participant Global Assessment of Treatment Satisfaction Score
기간: Screening, Day 29, and Day 57
|
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied).
Lower scores indicate greater satisfaction.
|
Screening, Day 29, and Day 57
|
|
[Step 1] Physician Global Assessment of Disease Severity Score
기간: Screening, Day 29, and Day 57
|
Disease/contracture severity will be assessed by the investigator using a study-specific 4-point scale (1 = Normal, 2 = Mild, 3 = Moderate, 4 = Severe).
Higher scores indicate greater severity.
|
Screening, Day 29, and Day 57
|
|
[Step 1] Physician Global Assessment of Treatment Satisfaction Score
기간: Screening, Day 29, and Day 57
|
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied).
Lower scores indicate greater satisfaction.
|
Screening, Day 29, and Day 57
|
|
[Step 1] Peak plasma concentration (Cmax) of CNXT1 and CNXT2
기간: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
|
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
|
[Step 1] Time to peak plasma concentration (tmax) of CNXT1 and CNXT2
기간: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
|
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
|
[Step 1] Area under the plasma concentration-time curve (AUC) of CNXT1 and CNXT2
기간: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
|
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
|
[Step 1] Half-life (t½) of CNXT1 and CNXT2
기간: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
|
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
|
[Step 1] Clearance (CL) of CNXT1 and CNXT2
기간: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
|
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
|
[Step 1] Volume of distribution (Vd/F) of CNXT1 and CNXT2
기간: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
|
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
|
|
[Step 1] Incidence of anti-drug antibodies against CNXT1 and CNXT2
기간: Day 1 (pre-dose), Day 15, 29, and Day 57
|
Antibody incidence, titers, and neutralizing antibodies assessed from blood samples.
|
Day 1 (pre-dose), Day 15, 29, and Day 57
|
|
[Step 2] Proportion of participants achieving contracture ≤5° of normal extension at Day 85 after first injection
기간: Day 85 after first injection
|
Assessed by finger goniometry.
|
Day 85 after first injection
|
|
[Step 2] Proportion of participants achieving contracture ≤5° of normal extension within 29 days after the last injection
기간: Within 29 days after last injection
|
Assessed by finger goniometry.
|
Within 29 days after last injection
|
|
[Step 2] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
기간: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
Assessed by finger goniometry at each scheduled visit.
|
Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Mean percent change in degree of contracture
기간: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
Assessed by finger goniometry (MP and PIP joints).
|
Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Time to clinical success (contracture ≤5°)
기간: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
Defined as the first study day on which treated joint contracture is ≤5°.
|
Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Change in range of motion (full extension, full flexion, and total arc)
기간: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
Assessed by finger goniometry (MP and PIP joints).
|
Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Participant Global Assessment of Treatment Satisfaction Score
기간: Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
|
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied).
Lower scores indicate greater satisfaction.
|
Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Physician Global Assessment of Disease Severity Score
기간: Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
|
Disease/contracture severity will be assessed by the investigator using a study-specific 4-point scale (1 = Normal, 2 = Mild, 3 = Moderate, 4 = Severe).
Higher scores indicate greater severity.
|
Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Physician Global Assessment of Treatment Satisfaction Score
기간: Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
|
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied).
Lower scores indicate greater satisfaction.
|
Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
|
|
[Step 2] Time to recurrence
기간: Month 2, 3, 4, 6, 9, and Month 12
|
Defined as an increase in joint contracture to ≥20° in the presence of a palpable cord.
|
Month 2, 3, 4, 6, 9, and Month 12
|
|
[Step 2] Proportion of participants with contracture recurrence at Month 12
기간: Month 12
|
Recurrence defined as joint contracture ≥20° in the presence of a palpable cord.
|
Month 12
|
|
[Step 2] Incidence of anti-drug antibodies against CNXT1 and CNXT2
기간: Screening, Day 1 of Cycle 1, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
Antibody incidence, titers, and neutralizing antibodies assessed from blood samples.
|
Screening, Day 1 of Cycle 1, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 7월 23일
기본 완료 (추정된)
2027년 7월 1일
연구 완료 (추정된)
2027년 7월 25일
연구 등록 날짜
최초 제출
2024년 8월 23일
QC 기준을 충족하는 최초 제출
2026년 6월 5일
처음 게시됨 (실제)
2026년 6월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 10일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- DC2201
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
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