A Phase I Clinical Trial of BAT4406F Injection on the Safety, Tolerability, and Pharmacokinetics in Patients With Neuromyelitis Optica Spectrum Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity（DLT）
研究概览
简要总结
This study is a phase I clinical study of the safety, tolerability, and pharmacokinetics of BAT4406F injection in patients with neuromyelitis optica spectrum disorders.
详细描述
This is a Phase 1, open-label, dose-escalation study in NMOSD patients in which subjects will receive BAT4406F injection via intravenous infusion. A 3 + 3 design will be utilized to define a maximum tolerated dose (MTD). The overall objective is to assess the safety, tolerability, and pharmacokinetics of BAT4406F injection in NMOSD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Compliance with the NMOSD diagnostic criteria developed by the 2015 International NMO Diagnostic Team (IPND);
- •18-65 years old , male or female;
- •At least 2 relapses occurred within 2 years before screening, or at least 1 relapse within 1 year before screening;
- •Discontinue the immunosuppressive agents such as azathioprine within 28 days before the baseline;
- •EDSS score ≤ 6;
- •Men and women with fertility must agree to use effective methods of contraception during treatment and within 12 months of treatment completion;
- •Agree to participate in the trial and sign the informed consent in writing.
排除标准
- •Any monoclonal antibody treatment was used within 6 months prior to dosing;
- •Having been treated with anti-CD20 monoclonal antibody;
- •Live vaccine received within 4 weeks before screening;
- •Having participated in another clinical study within 1 month or 5 half-lives of the drug prior to the baseline (whichever is longer);
- •A history of allergies to monoclonal antibodies; severe allergic reaction to certain foods or drugs;
- •Abnormal liver function, kidney function and bone marrow reserve;
- •HIV-positive history or HIV-positive at screening; hepatitis B and/or hepatitis C history or hepatitis B surface antigen-positive at screening; or hepatitis C virus (HCV) antibody positive; treponema pallidum antibody positive when enrolled;
- •History of infections that investigators have identified as unsuitable for testing;
- •Patients with a clear history of heart disease ;
- •Have a history of mental disorders;
- •Pregnant or lactating women, and female subjects who have a positive pregnancy test at screening;
- •None of the investigators or their relatives participating in the study could be enrolled.
研究组 & 干预措施
BAT4406F
干预措施: BAT4406F (Drug)
结局指标
主要结局
Dose-limiting toxicity（DLT）
时间窗: 4weeks
Safety and tolerability endpoint
Area under the curve (AUC)
时间窗: up to 6 months
Pharmacokinetic endpoint
Maximum tolerated dosed (MTD)
时间窗: up to 6 months
Safety and tolerability endpoint
Maximum serum drug concentration (Cmax)
时间窗: up to 6 months
Pharmacokinetic endpoint
Half-life period(t1/2)
时间窗: up to 6 months
Pharmacokinetic endpoint
Maximum serum drug time (Tmax)
时间窗: up to 6 months
Pharmacokinetic endpoint
CD19+ B lymphocyte ratio
时间窗: up to 6 months
Pharmacodynamics endpoint
次要结局
未报告次要终点