A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA).
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: KT501.
- Кому может быть актуально
- Состояния в реестре: Rheumatoid Arthritis (RA). Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австралия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase 1a, Open-Label, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KT501 by a Single Subcutaneous Administration in Participants With Rheumatoid Arthritis
Обзор
This is a Phase 1, open-label, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT501 administered subcutaneously to participants with Rheumatoid Arthritis (RA).
Подробное описание
This is a Phase 1, open-label, first-in-human dose escalation study to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic of KT501 by a single subcutaneous administration in participants with Rheumatoid Arthritis (RA).
Up to a total of 5 cohorts with up to approximately 24 participants in total with RA will be enrolled. All participants will receive a single dose of KT501 on Day 1 and followed up until Week 12. For any participants with B cells lower than baseline level or lower limit quantification, whichever is lower, additional B cell follow up is required up to Week 48 after the study treatment.
Вмешательства
- Препарат KT501
KT501 is a monoclonal antibody that depletes B cells including plasma cells by targeting CD19, BCMA and CD3.
Первичные конечные точки
- Incidence of Adverse Events [Срок оценки: From Baseline Up to 12 weeks]
- Incidence of Cytokine-release Syndrome (CRS) [Срок оценки: From Baseline Up to 12 Weeks]
- Changes in Pulse Rate from Baseline [Срок оценки: From Baseline Up to 12 Weeks]
- Changes in Respiratory Rate from Baseline [Срок оценки: From Baseline to 12 Weeks]
- Changes in Blood Pressure from Baseline [Срок оценки: From Baseline Up to Week 12]
- Changes in Temperature from Baseline [Срок оценки: From Baseline to 12 Weeks]
- Changes in Hematology Clinical Laboratory Results from Baseline [Срок оценки: From Baseline Up to 12 Weeks]
- Changes in Chemistry Clinical Laboratory Results from Baseline [Срок оценки: From Baseline Up to 12 Weeks]
- Changes in Urinalysis Clinical Laboratory Results from Baseline [Срок оценки: From Baseline Up to 12 Weeks]
- Changes in Coagulation Clinical Laboratory Results from Baseline [Срок оценки: From Baseline Up to 12 Weeks]
Вторичные конечные точки (12)
- Serum Concentrations of KT501 [Срок оценки: Pre-dose and 6 hours post-dose on Day 1; Day 2, 3, 4, 5, 8, 11, 15, 22, 29, 43, 57 and 85.]
- Incidence of Treatment-induced Anti-Drug Antibodies (ADAs) [Срок оценки: Pre-dose and on Day 1; Day 8, 11, 15, 22, 29, 43, 57 and 85.]
- To Determine Cmax [Срок оценки: Day 1 - Day 85]
- To Determine Tmax, Derived from Serum Concentration of each Dose of KT501 [Срок оценки: Day 1 - Day 85]
- Area Under the Serum-concentration Time Curve (AUC) from Time Zero to the Last Timepoint with Measurable Analyte Concentration (AUC0-t) [Срок оценки: Day 1 - Day 85]
- AUC from Time Zero to Infinity (AUCinf) [Срок оценки: Day 1 - Day 85]
- To Determine Terminal Half-Life (T1/2) [Срок оценки: Day 1 - Day 85]
- Total Body Clearance (CL/F) [Срок оценки: Day 1 - Day 85]
- Volume of Distribution During the Terminal Phase (Vz/F) [Срок оценки: Day 1 - Day 85]
- Change in Levels of B Cell Count [Срок оценки: Pre-dose on Day 1; Day 2, 3, 4, 5, 8, 11, 15, 22, 29, 43, 57 and 85.]
- Duration of B Cell Depletion [Срок оценки: Day 1 - Day 85]
- Change in Levels of Acute Inflammatory Markers [Срок оценки: Pre-dose and 6 hours post-dose on Day 1; Day 2, 3, 4, 5, 8, 15, 22, 29,, 57 and 85.]
Критерии участия
Критерии включения
- 18 to 75 years old
- Diagnosis of adult-onset RA for at least 6 months
- Moderately to severely active RA
- Inadequate treatment response as defined in the protocol
- RF + or ACPA+
- Stable use of traditional DMARDs is permitted
- Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Критерии исключения
- Functional class IV as defined by the ACR Classification of Functional Status in RA
- Presence of any concomitant autoimmune disease other than RA
- Active infection, history of serious recurrent or chronic infection
- History of progressive multifocal leukoencephalopathy
- Have a diagnosis or history of malignant disease within 5 years or breast cancer diagnosed within the previous 10 years.
- History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation
- Receipt of live vaccine within 4 weeks
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after study
- Women who are pregnant or breastfeeding
- Significant or uncontrolled medical disease that would preclude participant participation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Австралия · 1 центр
- Kali Study Site — Bayswater
Идентификаторы
NCT: NCT07234773 · KT501-001