A Phase 1/2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis.
3 de septiembre de 2026 actualizado por: 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).
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
44
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Sergio Rodriguez
- Número de teléfono: (646) 597-6980
- Correo electrónico: info@proliumbio.com
Ubicaciones de estudio
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Victoria
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Melbourne, Victoria, Australia, 3004
- Terminado
- Nucleus Network
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Seoul, Corea del Sur
- Reclutamiento
- Seoul National University Hospital
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Contacto:
- Sergio Rodriguez
- Número de teléfono: (646) 597-6980
- Correo electrónico: info@proliumbio.com
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Chihuahua City, México
- Reclutamiento
- Hospital Angeles Chihuahua
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Contacto:
- Sergio Rodriguez
- Número de teléfono: (646) 597-6980
- Correo electrónico: info@proliumbio.com
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San Nicolás de los Garza, México
- Reclutamiento
- Unidad Médica para la Salud Integral (UMSI)
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Contacto:
- Sergio Rodriguez
- Número de teléfono: (646) 597-6980
- Correo electrónico: info@proliumbio.com
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Beijing, Porcelana
- Reclutamiento
- Peking University Third Hospital
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Contacto:
- Sergio Rodriguez
- Número de teléfono: (646) 597-6980
- Correo electrónico: info@proliumbio.com
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Guangzhou, Porcelana
- Reclutamiento
- The third affiliated hospital of Sun Yat-Sen University
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Contacto:
- Sergio Rodriguez
- Número de teléfono: (646) 597-6980
- Correo electrónico: info@proliumbio.com
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Guangzhou, Porcelana
- Reclutamiento
- Guangdong Provincial People's Hospital
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Contacto:
- Sergio Rodriguez
- Número de teléfono: (646) 597-6980
- Correo electrónico: info@proliumbio.com
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Nanchang, Porcelana
- Reclutamiento
- The First Affiliated Hospital of Nanchang University
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Contacto:
- Sergio Rodriguez
- Número de teléfono: (646) 597-6980
- Correo electrónico: info@proliumbio.com
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Nanchang, Porcelana
- Reclutamiento
- The Second Affiliated Hospital of Nanchang University
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Contacto:
- Sergio Rodriguez
- Número de teléfono: (646) 597-6980
- Correo electrónico: info@proliumbio.com
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Nanjing, Porcelana
- Reclutamiento
- Nanjing Drum Tower Hospital
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Contacto:
- Sergio Rodriguez
- Número de teléfono: (646) 597-6980
- Correo electrónico: info@proliumbio.com
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Pingxiang, Porcelana
- Reclutamiento
- Pingxiang People's Hospital
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Contacto:
- Sergio Rodriguez
- Número de teléfono: (646) 597-6980
- Correo electrónico: info@proliumbio.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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:
- relative decline in forced vital capacity (FVC) % predicted ≥ 10%, or
- relative decline in FVC % predicted ≥ 5% to <10% and worsened respiratory symptoms, or
- relative decline in FVC % predicted ≥ 5% to <10% and increased extent of fibrosis on high-resolution computed tomography (HRCT), or
- 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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Part 1: Placebo
Matching SC placebo administered to randomized Part 1 participants
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Matching placebo comparator for Part 1 participants.
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Experimental: Part 1: PRO-203
Healthy participants receive single ascending dose of PRO-203 in dose escalation cohorts
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PRO-203 administered as escalating single dose in healthy participants or as a single cycle in participants with systemic sclerosis.
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Experimental: 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.
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PRO-203 administered as escalating single dose in healthy participants or as a single cycle in participants with systemic sclerosis.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of Adverse Events and Laboratory Abnormalities [Safety and Tolerability]
Periodo de tiempo: 13 weeks (Part 1) / 49 weeks (Part 2)
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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.
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13 weeks (Part 1) / 49 weeks (Part 2)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pharmacokinetics of PRO-203
Periodo de tiempo: 13 weeks (Part 1) / 49 weeks (Part 2)
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Serum drug levels of PRO-203 over time
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13 weeks (Part 1) / 49 weeks (Part 2)
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Pharmacodynamic-related biomarkers of PRO-203
Periodo de tiempo: 13 weeks (Part 1) / 49 weeks (Part 2)
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Peripheral blood B lymphocyte levels over time
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13 weeks (Part 1) / 49 weeks (Part 2)
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Immunogenicity of PRO-203
Periodo de tiempo: 13 weeks (Part 1) / 49 weeks (Part 2)
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Level of anti-drug antibodies
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13 weeks (Part 1) / 49 weeks (Part 2)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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FVC % Predicted (Part 2)
Periodo de tiempo: 13 weeks / 49 weeks
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Change from baseline in forced vital capacity (FVC) as a percentage of predicted normal.
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13 weeks / 49 weeks
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Diffusing Capacity for Carbon Monoxide (DLCO) (Part 2)
Periodo de tiempo: 13 weeks / 49 weeks
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Change from baseline in diffusing capacity for carbon monoxide (DLCO) as a percentage of predicted normal.
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13 weeks / 49 weeks
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Modified Rodnan Skin Score (mRSS) (Part 2)
Periodo de tiempo: 13 weeks /49 weeks
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Change from baseline in Modified Rodnan Skin Score (mRSS) on a scale of 0 to 51, with a higher score indicating greater skin thickening.
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13 weeks /49 weeks
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Revised Composite Response Index in Systemic Sclerosis (rCRISS) (Part 2)
Periodo de tiempo: 13 weeks / 49 weeks
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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.
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13 weeks / 49 weeks
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European Scleroderma Trials and Research Group Activity Index (EUSTAR-AI) (Part 2)
Periodo de tiempo: 13 weeks / 49 weeks
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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.
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13 weeks / 49 weeks
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Health Assessment Questionnaire - Disability Index (HAQ-DI) (Part 2)
Periodo de tiempo: 13 weeks / 49 weeks
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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.
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13 weeks / 49 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Salim Mujais, Prolium Bioscience, Inc
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
27 de octubre de 2025
Finalización primaria (Estimado)
1 de enero de 2027
Finalización del estudio (Estimado)
1 de enero de 2028
Fechas de registro del estudio
Enviado por primera vez
10 de diciembre de 2025
Primero enviado que cumplió con los criterios de control de calidad
7 de junio de 2026
Publicado por primera vez (Actual)
11 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PRO-203-101
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .