NCT05668403招募中1 期
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
Shanghai Jiaolian Drug Research and Development Co., Ltd5 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年3月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- Dose limiting toxicity（DLT）
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
B007:350mg
Experimental
B007:350mg Subcutaneous injection was administered on days 1 and 15
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
干预措施: B007 (Drug)
B007:700mg
Experimental
B007: 700mg Subcutaneous injection was administered on days 1 and 15
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
干预措施: B007 (Drug)
B007:1000mg
Experimental
B007: 1000mg Subcutaneous injection was administered on days 1 and 15
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
干预措施: B007 (Drug)
结局指标
主要结局
Dose limiting toxicity（DLT）
时间窗: Approximately 1 years
Adverse reactions that are certainly or possibly related to the drug being tested during the dose escalation phase.
Security: Incidence of Treatment-Emergent Adverse Events
时间窗: Approximately 2 years
Adverse event type, incidence, duration, correlation with study drug
次要结局
- Immunogenicity(Approximately 1 years)
- Biomarkers(Approximately 1 years)
- Dynamics of pharmacodynamics(Approximately 1 years)
- PK (Pharmacokinetics)(Approximately 1 years)
- Proportion of subjects achieving clinical remission(Approximately 2 years)
研究者
研究点 (5)
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