A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal Antibody Subcutaneous Injection in the Treatment of Primary Membranous Nephropathy

Официальное название

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy

Обзор

This Phase I Clinical Study assessed the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy

Вмешательства

• Препарат B007
  Drug: B007 injection Drug: Placebo injection
• Препарат B007
  Drug: B007 injection Drug: Placebo injection
• Препарат B007
  Drug: B007 injection Drug: Placebo injection

Первичные конечные точки

• Dose limiting toxicity（DLT） [Срок оценки: Approximately 1 years]
• Security: Incidence of Treatment-Emergent Adverse Events [Срок оценки: Approximately 2 years]

Вторичные конечные точки (7)

• PK (Pharmacokinetics) [Срок оценки: Approximately 1 years]
• PK (Pharmacokinetics) [Срок оценки: Approximately 1 years]
• PK (Pharmacokinetics) [Срок оценки: Approximately 1 years]
• Biomarkers [Срок оценки: Approximately 1 years]
• Immunogenicity [Срок оценки: Approximately 1 years]
• Dynamics of pharmacodynamics [Срок оценки: Approximately 1 years]
• Proportion of subjects achieving clinical remission [Срок оценки: Approximately 2 years]

Критерии участия

Критерии включения

• Subjects who have fully understood this study and voluntarily signed the informed consent form;
• Male or female subjects, aged between 18 and 75 years;
• Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
• Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening;
• If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
• Subjects who are able to follow the study protocol as judged by the investigator.

Критерии исключения

• Subjects with secondary membranous nephropathy;
• Subjects with uncontrolled blood pressure as judged by the investigator within 3 months before screening;
• Subjects with decreases in urine protein ≥ 50% within 6 months before screening;
• Subjects who have received or are receiving renal replacement therapy;
• Subjects with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;
• Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
• Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy;
• Subjects with known history of severe allergic reactions to humanized monoclonal antibodies；
• Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
• Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;
• Subjects with serious, progressive, or uncontrolled disease that may increase risks during the participation in the study as assessed by the investigator;
• Subjects with a history of alcoholism or drug abuse within 12 months;
• Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency;
• Subjects with CD4+ T lymphocyte count < 300 cells/μL;
• Other conditions unsuitable for participation in this study determined by the Investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Hebei General Hospital — Shijiazhuang
• The First Affiliated Hospital,College of Medicine,Zhejiang University — Ханчжоу
• Peking university first hospital — Пекин
• Longhua Hospital Shanghai University of Traditional Chinese Medicine — Шанхай
• Longhua Hospital Shanghai University of Traditional Chinese Medicine — Шанхай

Идентификаторы

NCT: NCT05668403 · B007-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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