EUCTR2021-006223-18-DE进行中（未招募）1 期
A randomized open-label Phase 2a study to assess the pharmacokinetics and pharmacodynamic parameters of PXL770 after 12 weeks of treatment in male subjects with adrenomyeloneuropathy (AMN) - START770
Poxel S.A.0 个研究点目标入组 24 人开始时间: 2022年1月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Male subjects with either a confirmed diagnosis of AMN by genetic testing or a family history of ALD together with an elevation in VLCFA obtained from overnight fasting plasma sample at V1 (Screening Visit).
- •2. Age: = 18 to = 65 years at informed consent signature.
- •3. Normal brain MRI or brain MRI showing non-specific abnormalities that can be observed in AMN subjects without signs of C-ALD
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Target disease exclusions
- •1. Any progressive neurological disease other than AMN.
- •2. Arrested or progressing C-ALD as defined by cerebral lesions.
- •3. Prior receipt of an allogeneic hematopoietic stem cell transplant or gene therapy.
研究者
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