NCT06848231进行中（未招募）2 期
A Double-Blind, Placebo-Controlled, Multi-Center, Phase II, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of YA-101 in Subjects With Multiple System Atrophy
Dasher Neuroscience Inc.21 个研究点 分布在 3 个国家目标入组 75 人开始时间: 2025年3月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 21
- 主要终点
- Incidence and severity of Adverse Events (AEs)
研究概览
简要总结
This is a Phase 2, double-blind, placebo-controlled, multi-center, Phase II, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of Ya-101 in subjects with multiple system atrophy.
详细描述
The purpose of the study is to evaluate 2 doses of YA-101 compared to placebo in MSA patients, including: 1) safety and tolerability, 2) pharmacokinetics, and 3) potential efficacy of YA-101.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand the process of the clinical trial and give informed consent for the participation of the study.
- •Diagnosis of MSA according to MDS clinical criteria (Wenning et al, 2022), including subjects with MSA of either subtype (MSA-P or MSA-C).
- •Males or non-pregnant, non-lactating females with no child-bearing potential, or agree to use 2 forms of contraception.
- •Able to take oral medications.
- •Able to ambulate without the assistance of another person.
排除标准
- •Positive urine test for drugs of abuse and/or alcohol test both at screening and Day
- •Evidence of renal impairment or hepatic impairment.
- •Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower.
- •Medical history includes severe systemic diseases such as cardiopulmonary failure, severe liver or kidney disease, and uncontrolled diabetes; significant central nervous system disorders like stroke, encephalitis, and epilepsy and severe head trauma; peptic ulcer in one year prior to screening.
- •Positive results for active viral infections, including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
YA-101
Experimental
干预措施: YA-101 (Drug)
结局指标
主要结局
Incidence and severity of Adverse Events (AEs)
时间窗: Baseline to Day 112
Incidence and severity of Adverse Events (AEs).
次要结局
- Maximum observed concentration (Cmax)(Baseline to Day 84)
- Area under the concentration-time curve (AUC)(Baseline to Day 84)
- Time of maximum observed concentration (Tmax)(Baseline to Day 84)
- Change from baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) over time(Baseline to Day 112)
- Change from baseline in the 10-meter walking test(Baseline to Day 112)
研究者
研究点 (21)
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