NCT05145361招募中1 期
A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening
- •Clinical evidence of at least 1 documented relapse in last 12 months prior to screening
- •Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening
- •Age 18 to 70 years, inclusive at the time of informed consent
排除标准
- •Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline.
- •Received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine A, etc, and rug therapy, biological agents such as satralizumab, tocilizumab, eculizumab, etc, 3 months prior to the first administration.
- •Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
- •Known active infection within 3 months prior to baseline
- •Pregnancy or lactation.
- •History of severe allergic reaction to a biologic agent
- •Evidence of chronic active hepatitis B or C
- •Evidence of active tuberculosis
- •Following laboratory abnormalities at screening*:
- •White blood cells (WBC) <4.0 x10^3/microliter (μL)
- •Absolute neutrophil count (ANC)
- •Absolute lymphocyte count <0.5 x10^3/μL
- •Platelet count <80 x 10^9/ L
- •Aspartate aminotransferase (AST) or alanine aminotransferase
- •History of drug or alcohol abuse within 6 months prior to baseline
- •Receipt of any live or live attenuated vaccine within 4 weeks prior to baseline
- •Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes, gastrointestinal diseases, etc.; or the investigator believes that there is anything inappropriate reasons for selection.
研究组 & 干预措施
B001 injection
Experimental
Subjects randomized to this arm will receive B001 twice, at day 1 and day 15, up to the end of the study.
干预措施: B001 injection (Drug)
Placebo
Placebo Comparator
Subjects randomized to this arm will receive Placebo twice, at day 1 and day 15, up to the end of the study.
干预措施: Placebo (Biological)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Up to 18 days.
Measurement of DLT in all subjects.
Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability].
时间窗: Up to 1 year
次要结局
- Accumulation ratio of maximum serum concentration (Rac_Cmax) of B001.(Through study completion, up to 2 years)
- Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14D) of B001.(Through study completion, up to 2 years)
- Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of B001.(Through study completion, up to 2 years)
- Time of maximum serum concentration (Tmax) of B001.(Through study completion, up to 2 years)
- Maximum serum concentration (Cmax) of B001.(Through study completion, up to 2 years)
- Terminal rate constant(λz) of B001.(Through study completion, up to 2 years)
- Half-life (t1/2) of B001.(Through study completion, up to 2 years)
- Percentage of area under the serum concentration-time curve (AUC 0-infinity) obtained by extrapolation (%AUCex) of B001.(Through study completion, up to 2 years)
- Change in Expanded Disability Status Scale (EDSS) Score(Through study completion, up to 2 years)
- Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period(Through study completion, up to 2 years)
- Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of B001.(Through study completion, up to 2 years)
- Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of B001.(Through study completion, up to 2 years)
- Volume of distribution(Vz) of B001.(Through study completion, up to 2 years)
- Percentage of subjects with ADA to B001 and neutralizing resistance (Nab)(Through study completion, up to 2 years)
- Total clearance(CL) of B001.(Through study completion, up to 2 years)
- Time to EDSS Worsening(Through study completion, up to 2 years)
研究者
研究点 (4)
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