A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis

Официальное название

A Phase IIa, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis

Обзор

The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.

Вмешательства

• Препарат SV001
  SV001 ： Multiple-dose
• Препарат Placebo
  Placebo ： Multiple-dose

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events [Срок оценки: Approximately 1 years]

Вторичные конечные точки (5)

• Peak Plasma Concentration (Cmax) [Срок оценки: Approximately 1 years]
• Peak time（Tmax） [Срок оценки: Approximately 1 years]
• Area under the plasma concentration versus time curve (AUC) [Срок оценки: Approximately 1 years]
• half-life（T1/2） [Срок оценки: Approximately 1 years]
• Immunogenicity [Срок оценки: Approximately 1 years]

Критерии участия

Критерии включения

• Subjects with a confirmed diagnosis of IPF and pulmonary function meeting the protocol-specified criteria;
• Subjects must agree to use highly effective contraception during the study and for 6 months after the last administration of the study drug;
• Subjucts must be able to understand the study, voluntarily provide written informed consent, and be willing and able to comply with all study-related procedures.

Критерии исключения

• Subjects with a history of drug or other allergies, or those judged by the investigator to be potentially allergic to the study drugs;
• Presence of any other clinically significant pulmonary diseases besides IPF at screening;
• Any known contraindications to performing pulmonary function tests at screening;
• Respiratory or systemic infections requiring anti-infective therapy within 1 month prior to randomization;
• Acute exacerbation of IPF within 4 months prior to randomization;
• Use of any medication known to cause or worsen pulmonary fibrosis, as assessed by the investigator, within 3 months prior to screening;
• History of smoking within 3 months prior to screening, or unwillingness to quit smoking throughout the study period;
• Presence of clinically significant cardiovascular, cerebrovascular, hematological, neurological, psychiatric, or metabolic disease at screening, or plans for major surgery during the study period;
• Presence of specified abnormal laboratory test results at screening;
• Evidence of renal impairment or end-stage renal disease requiring dialysis at screening;
• Active hepatitis virus infection; history of acquired or congenital immunodeficiency disease;
• History of malignancy within 5 years prior to screening;
• Difficulty with venipuncture or a history of needle phobia or blood phobia;
• Positive pregnancy tests or currently lactating at screening;
• Participation in another clinical trial and receipt of other investigational drugs within 3 months prior to randomization;
• Any other condition that the investigator consider unsuitable for participation in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 12 центров

• Sichuan Provincial People's Hospital — Чэнду
• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• Hangzhou First People's Hospital — Ханчжоу
• The First Affiliated Hospital of Nanchang University — Nanchang
• Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School — Нанкин
• The Affiliated Hospital of Inner Mongolia Medical University — Neimeng
• Dongfang Hospital Affiliated to Tongji University — Шанхай
• Huadong Hospital Affiliated to Fudan University — Шанхай
• … и ещё 4 центра

Идентификаторы

NCT: NCT07121413 · SV001-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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