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A Phase 1/2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis.

2026년 9월 3일 업데이트: Prolium Bioscience, Inc

A Two-part, Phase 1/2, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study of PRO-203 in Healthy Adult Volunteers Followed by an Open-label, Single-ascending-dose With Priming Study of PRO-203 in Participants With Systemic Sclerosis

A two-part study of PRO-203 administered subcutaneously in healthy adult volunteers and participants with Systemic Sclerosis (SSc).

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This two-part study is designed to characterize the first-in-human safety, tolerability, PK, and PD profile of PRO-203 across ascending dose levels.

Part 1 - Healthy Volunteers (HV) Part 1 enrollment is complete and has enrolled 20 healthy volunteers across 3 cohorts. Participants within each cohort received a single SC dose of PRO-203 or matching placebo. Part 1 has completed enrollment.

Part 2 - Systemic Sclerosis (SSc) Up to 24 participants with SSc will be enrolled in multiple cohorts (with optional additional cohorts) Participants within each cohort will receive a single SC cycle of PRO-203. Part 2 includes a Main Study and an optional Long-term Extension (LTE). In the LTE, eligible participants may receive retreatment if they meet retreatment criteria. Total study duration per participant is up to 53 weeks.

연구 유형

중재적

등록 (추정된)

44

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대한민국
      • Seoul, 대한민국
        • 모병
        • Seoul National University Hospital
        • 연락하다:
  • 멕시코
      • Chihuahua City, 멕시코
        • 모병
        • Hospital Angeles Chihuahua
        • 연락하다:
      • San Nicolás de los Garza, 멕시코
        • 모병
        • Unidad Médica para la Salud Integral (UMSI)
        • 연락하다:
  • 중국
      • Beijing, 중국
        • 모병
        • Peking University Third Hospital
        • 연락하다:
      • Guangzhou, 중국
        • 모병
        • The third affiliated hospital of Sun Yat-Sen University
        • 연락하다:
      • Guangzhou, 중국
        • 모병
        • Guangdong Provincial People's Hospital
        • 연락하다:
      • Nanchang, 중국
        • 모병
        • The First Affiliated Hospital of Nanchang University
        • 연락하다:
      • Nanchang, 중국
        • 모병
        • The Second Affiliated Hospital of Nanchang University
        • 연락하다:
      • Nanjing, 중국
        • 모병
        • Nanjing Drum Tower Hospital
        • 연락하다:
      • Pingxiang, 중국
        • 모병
        • Pingxiang People's Hospital
        • 연락하다:
  • 호주
    • Victoria
      • Melbourne, Victoria, 호주, 3004
        • 완전한
        • Nucleus Network

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

Key Inclusion Criteria (All Participants)

  • Is male or female, age 18 to 65 years, inclusive, at Screening.
  • Able to provide Informed Consent.
  • Absolute B cell count > 25 cells/uL.

Additional Inclusion for Part 1 (Closed to Enrollment)

  • In good general health, determined by no clinically significant findings in the of the investigator from medical history, physical examination, 12-lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1 (participants with Gilbert's disease with associated abnormalities of liver function tests are eligible for enrollment).
  • Up to date vaccination status per local guidelines (including but not limited to influenza vaccine, COVID booster and hepatitis B vaccine).

Additional Inclusion for Part 2

  • Fulfill 2013 ACR/ EULAR criteria for classification of SSc with a total score of ≥ 9.
  • Active disease defined as at least two of the following at screening:
  • Disease duration ≤ 2 years (since onset of first-non-Raynaud-symptom), or
  • Elevated acute phase reactant levels (CRP ≥ 6 mg/L, erythrocytes sedimentation rate [ESR] ≥ 28 mm/1h, or platelet count ≥ 330,000/µL), or
  • Baseline mRSS ≥10 with evidence of progression, defined as mRSS increase at least 3 units, or involvement of 1 new body area and mRSS increase at least 2 units, or involvement of 2 new body areas (each within the previous 6 months), or
  • ≥ 1 tendon friction rub, or
  • Elevation of CK or aldolase > 2 × the upper limit of normal (ULN) consistent with SSc-related myopathy, or

  • Progressive fibrosing interstitial lung disease (ILD) as defined by at least one of the following criteria at any time within the prior 2 years:

    1. relative decline in forced vital capacity (FVC) % predicted ≥ 10%, or
    2. relative decline in FVC % predicted ≥ 5% to <10% and worsened respiratory symptoms, or
    3. relative decline in FVC % predicted ≥ 5% to <10% and increased extent of fibrosis on high-resolution computed tomography (HRCT), or
    4. worsened respiratory symptoms and increased extent of fibrosis on HRCT
  • Intolerant or refractory to at least 1 line of standard therapy, including methotrexate, azathioprine, IVIG, mycophenolic acid derivatives, cyclophosphamide, TNF-inhibitors, rituximab, or tocilizumab.

Key Exclusion Criteria (All Participants)

  • Any clinically significant underlying illness in the opinion of the investigator.
  • Active infection within 4 weeks prior to screening. Participants receiving IV antibiotics or having received IV antibiotics within 14 days prior to enrollment are excluded.
  • Positive QuantiFERON-Gold TB test at screening.
  • Plan to receive live, attenuated vaccine after signing ICF (inactive vaccines, such as the flu vaccine, are allowed).
  • Evidence of malignant disease or malignancies diagnosed within the previous 5 years (except for treated local basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that had been excised and cured).
  • Currently enrolled in another investigational device or drug study, or less than 30 days or 5 half-lives of the prior investigational agent (whichever is longer) have passed since ending another investigational device or drug study or plans to enroll in another investigational device or drug study during the course of this study.
  • Social smokers e.g. up to 10 cigarettes per week (or equivalent amounts of nicotine containing products) and willing to abstain during inpatient stay, are allowed

Additional Exclusion Criteria for Part 1 (Closed to Enrollment)

  • Use of any prescription medication within 14 days and OTC medications, vitamins, herbal medications (e.g., St. John's wort), or cannabis, except for contraceptive medications and as needed (prn) acetaminophen/paracetamol (not exceeding 2 grams/day) within 7 days prior to administration of the study drug and throughout the study.

Additional Exclusion Criteria for Part 2

  • Rheumatic autoimmune disease other than SSc.
  • Positive anti-centromere antibodies.
  • Pulmonary disease with FVC ≤ 45% of predicted, or DLCO ≤ 35% of predicted.
  • Class 2 or higher pulmonary arterial hypertension or evidence of other moderately severe pulmonary disease.
  • Renal crisis within 6 months prior to Screening.
  • Prior treatment with cellular immunotherapy (eg, CAR-T) or gene therapy product directed at any target.
  • Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation.
  • Previous treatment with thalidomide, anti-thymocyte globulin, plasmapheresis, or extracorporeal photopheresis.
  • Unable to washout current immunosuppressive therapy within 2 months
  • Has received anti-CD19 or CD20 therapies, within 6 months prior to start of therapy
  • Plan to receive live or live-attenuated vaccines within 8 weeks prior to first dose of study drug and during treatment until B cell reconstitution to 80% of baseline (inactive vaccines, such as the flu vaccine, are allowed)

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: 순차적 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Part 1: Placebo
Matching SC placebo administered to randomized Part 1 participants
다른: Placebo
Matching placebo comparator for Part 1 participants.
실험적: Part 1: PRO-203
Healthy participants receive single ascending dose of PRO-203 in dose escalation cohorts
의약품: PRO-203
PRO-203 administered as escalating single dose in healthy participants or as a single cycle in participants with systemic sclerosis.
실험적: Part 2: Multiple Doses of PRO-203
Participants with systemic sclerosis receive a single cycle of PRO-203 across cohorts, including additional treatment as needed.
의약품: PRO-203
PRO-203 administered as escalating single dose in healthy participants or as a single cycle in participants with systemic sclerosis.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Adverse Events and Laboratory Abnormalities [Safety and Tolerability]
기간: 13 weeks (Part 1) / 49 weeks (Part 2)
Incidence and severity of treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities, including changes in clinical laboratory values, ECGs, and vital signs.
13 weeks (Part 1) / 49 weeks (Part 2)

2차 결과 측정

결과 측정
측정값 설명
기간
Pharmacokinetics of PRO-203
기간: 13 weeks (Part 1) / 49 weeks (Part 2)
Serum drug levels of PRO-203 over time
13 weeks (Part 1) / 49 weeks (Part 2)
Pharmacodynamic-related biomarkers of PRO-203
기간: 13 weeks (Part 1) / 49 weeks (Part 2)
Peripheral blood B lymphocyte levels over time
13 weeks (Part 1) / 49 weeks (Part 2)
Immunogenicity of PRO-203
기간: 13 weeks (Part 1) / 49 weeks (Part 2)
Level of anti-drug antibodies
13 weeks (Part 1) / 49 weeks (Part 2)

기타 결과 측정

결과 측정
측정값 설명
기간
FVC % Predicted (Part 2)
기간: 13 weeks / 49 weeks
Change from baseline in forced vital capacity (FVC) as a percentage of predicted normal.
13 weeks / 49 weeks
Diffusing Capacity for Carbon Monoxide (DLCO) (Part 2)
기간: 13 weeks / 49 weeks
Change from baseline in diffusing capacity for carbon monoxide (DLCO) as a percentage of predicted normal.
13 weeks / 49 weeks
Modified Rodnan Skin Score (mRSS) (Part 2)
기간: 13 weeks /49 weeks
Change from baseline in Modified Rodnan Skin Score (mRSS) on a scale of 0 to 51, with a higher score indicating greater skin thickening.
13 weeks /49 weeks
Revised Composite Response Index in Systemic Sclerosis (rCRISS) (Part 2)
기간: 13 weeks / 49 weeks
Change from baseline in disease response as measured by the Revised Composite Response Index in Systemic Sclerosis (rCRISS), where a higher score indicates a better outcome.
13 weeks / 49 weeks
European Scleroderma Trials and Research Group Activity Index (EUSTAR-AI) (Part 2)
기간: 13 weeks / 49 weeks
Change from baseline in disease activity as measured by the European Scleroderma Trials and Research Group Activity Index (EUSTAR-AI) on a scale of 0 to 10, where a higher score indicates greater disease activity.
13 weeks / 49 weeks
Health Assessment Questionnaire - Disability Index (HAQ-DI) (Part 2)
기간: 13 weeks / 49 weeks
Change from baseline in physical function and disability as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) on a scale of 0 to 3, where a higher score indicates greater difficulty with daily activities.
13 weeks / 49 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Prolium Bioscience, Inc

수사관

  • 연구 책임자: Salim Mujais, Prolium Bioscience, Inc

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)

2025년 10월 27일

기본 완료 (추정된)

2027년 1월 1일

연구 완료 (추정된)

2028년 1월 1일

연구 등록 날짜

최초 제출

2025년 12월 10일

QC 기준을 충족하는 최초 제출

2026년 6월 7일

처음 게시됨 (실제)

2026년 6월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 3일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PRO-203-101

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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