Идёт набор NCT07564154

A First-in-human Study of KT502 in Adult Participants With Rheumatoid Arthritis (RA)

Фаза I С лечением 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: KT502.
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, Новая Зеландия
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 1, Open-Label, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KT502 by Subcutaneous Administration in Adult 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 KT502 administered subcutaneously to participants with Rheumatoid Arthritis (RA). The study will have 2 parts: Part A is a single ascending dose finding (SAD) and Part B is dose escalation by fractionated dosing.

Вмешательства

Препарат KT502
KT502 is a monoclonal antibody that depletes B cells by targeting CD19 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: Baseline to 12 Weeks]
Changes in Temperature from Baseline [Срок оценки: 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: 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 KT502 [Срок оценки: Part A: Pre-dose; Day 2, 3, 8, 15, 29 Part B (1st Dose): Pre-dose, Day 2, 3 Part B (2nd Dose): Pre-dose Day 8; Day 9, 10, 11, 15, 29, 43, 57 and 85]
Incidence of Treatment-induced Anti-Drug Antibodies (ADAs) [Срок оценки: Part A: Pre-dose; Day 8, 15, 22, 29, 43, 57 and 85 Part B (1st Dose): Pre-dose Part B (2nd Dose): Pre-dose Day 8; Day 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 KT502 [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: Screening; Day 1 - Day 85]
Duration of B Cell Depletion [Срок оценки: Day 1 - Day 85]
Change in Levels of Acute Inflammatory Markers [Срок оценки: Pre-dose; Day 2, 3, 4, 5, 8, 9, 10, 15, 22, 29, 43, 57 and 85]

Критерии участия

Inclusion:

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.

Exclusion:

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