A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)

Официальное название

A First-in-Human, Phase 1, Open-Label, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CPTX2309 by Intravenous Administration in Healthy Volunteers and Subjects With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)

Обзор

The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.

Подробное описание

A first-in-human Phase 1, open label study to evaluate safety and tolerability of a single ascending dose (SAD) and multiple ascending dose (MAD) of CPTX2309 intravenously administered to healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.

Вмешательства

• Препарат CPTX2309
  Intravenous Infusion
• Препарат CPTX2309
  Intravenous Infusion

Первичные конечные точки

• Number of participants with changes in the safety parameters [Срок оценки: Up to approximately 1 Year]
• Number of participants with clinical laboratory assessment abnormalities [Срок оценки: Up to approximately 1 Year]
• Number of participants with changes in the vital signs [Срок оценки: Up to approximately 1 Year]
• Number of participants with changes in the ECG [Срок оценки: Up to approximately 1 Year]
• Number of participants who develop anti-drug antibodies (ADAs) and Circulating Immune Complex (CIC) formation [Срок оценки: Up to approximately 1 Year]
• Part A and B: Number of participants with change from baseline in vaccine antibody titers [Срок оценки: Up to approximately 1 Year]
• Changes in serum cytokine and chemokine levels that are known to be associated with CAR-T cell therapy related toxicity [Срок оценки: Up to approximately 1 Year]
• Change from baseline in soluble immunoglobulins (Ig) [Срок оценки: Up to approximately 1 Year]
• Part C and D: Change from baseline in vaccination-induced antibody titers [Срок оценки: Up to approximately 1 Year]

Вторичные конечные точки (5)

• Pharmacokinetic Parameters [Срок оценки: Up to approximately 1 Year]
• Pharmacodynamic Parameters [Срок оценки: Up to approximately 1 Year]
• Part A and B: Pharmacodynamic Parameters [Срок оценки: Up to approximately 1 Year]
• Part A and B: Pharmacodynamic Parameters [Срок оценки: Up to approximately 1 Year]
• Part C and D: Number of Participants who develop ADAs [Срок оценки: Up to approximately 1 Year]

Критерии участия

Критерии включения

• Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period.
• Participant is willing and able to adhere to the study visit schedule and other protocol requirements.

RA Only:

• Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA
• Presence of rheumatoid factor or ACPA above the ULN
• Confirmation of at least moderate active disease at screening with the presence of at least 6 swollen and 6 tender joints at screening using the 68 (tender)/66 (swollen) joint count OR the presence of at least 3 joints with active synovitis via MRI assessment.

SLE Only:

• Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria for SLE
• Positive ANA>=1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double standard DNA (dsDNA) or anti-Smith (Sm).

Критерии исключения

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted.
• Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the first administration of CPTX2309.

RA Only:

\- Participants diagnosed with Felty's syndrome

SLE Only:

• Active neuropsychiatric SLE, as defined by the CNS portion of SLEDAI at Screening, or signs of symptoms of neuropsychiatric SLE within 6 months prior to Screening (lupus headache permissible)
• Note: Other protocol-defined inclusion/exclusion criteria apply

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 3 центра

• Nucleus Network Brisbane — Herston
• Veritus Research — Bayswater
• Linear Clinical Research — Nedlands

Идентификаторы

NCT: NCT06917742 · CPTX2309-01-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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