A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases

Официальное название

A Phase 1, First-In-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CND319 in Healthy Participants and Patients With Rheumatic Diseases

Обзор

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.

Подробное описание

This is a Phase 1, first-in-human, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy participants and patients with rheumatic diseases. The study consists of two parts: a dose escalation part and an open-label expansion.

Вмешательства

• Биопрепарат CND319
  CND319

Первичные конечные точки

• Incidence proportion and severity of treatment-emergent adverse events through end of study [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• Changes to body temperature [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• Changes to heart rate [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• Changes to respiratory rate [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• Changes to blood pressure [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• Changes to pulse oximetry [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• Changes from baseline in ECG parameters through end of study: PR interval [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• Changes from baseline in ECG parameters through end of study: QRS interval [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• Changes from baseline in ECG parameters through end of study: QT interval [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• Changes from baseline in safety laboratory assessments through end of study [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]

Вторичные конечные точки (8)

• PK parameters for CND319: Maximum observed concentration (Cmax) [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• PK parameters for CND319: Time to maximum observed concentration (Tmax) [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• PK parameters for CND319: Area under the concentration-time curve (AUC) [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• PK parameters for CND319: Apparent clearance (CL/F) [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• PK parameters for CND319: Apparent volume of distribution (Vz/F) [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• PK parameters for CND319: Terminal elimination half-life (t1/2) [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• Frequency of participants/patients with anti-drug antibodies (ADAs) [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]
• Percentage of participants/patients with anti-drug antibodies (ADAs) [Срок оценки: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)]

Критерии участия

Inclusion Criteria (SAD):

• 18 to 65 years old
• Body mass index 18-30 kg/m2 and weight 55-100 kg
• Individuals in good health
• Agree to abstain from consumption of alcohol 48 hours prior to study visits
• Agree to the use of highly effective contraception as defined in the protocol

Inclusion Criteria (MAD and Part 2 Expansion):

Patients with RA:

• 18 to 75 years old
• Diagnosis of adult-onset RA
• Class I-III RA
• Moderately to severely active RA

Patients with SjD:

• 18 to 75 years old
• Diagnosis of primary SjD

Exclusion Criteria (SAD):

• Inadequate clinical laboratory parameters at Screening
• Active infection
• Receipt of or inability to discontinue any excluded therapies
• Individuals with immediate household contact with your children (eg, ≤ 6 years old) or immunocompromised persons
• History of alcohol or drug abuse within last 12 months
• Positive alcohol breathalyzer or drug screen prior to dosing
• Inability to comply with protocol-mandated requirements
• History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant anti-body-related fusion proteins) or any constituents of study drug
• Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study
• Blood donation or significant blood loss within 30 days
• Individuals considered to be part of a vulnerable population (eg, incarceration)
• Individuals that in the opinion of the Investigator, are not suitable for participation in the trial

Exclusion Criteria for patients with RA or SjD:

• Inadequate clinical laboratory parameters at Screening
• Active infection
• Receipt of or inability to discontinue any excluded therapies
• History of progressive multifocal leukoencephalopathy
• Central nervous system disease
• Presence of 1 or more significant concurrent medical conditions
• Have a diagnosis or history of malignant disease within 5 years
• History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of study drug
• Women who are pregnant or breastfeeding
• Patients who do not agree to the use of highly effective contraception as defined by the protocol

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Candid Clinical Site — Melbourne

Идентификаторы

NCT: NCT07712939 · CND319-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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