ISRCTN14792372进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, single- and multiple-, ascending-dose study of the safety, tolerability, and pharmacokinetics and pharmacodynamics of VRG50635 and food effect in healthy volunteers (phase Ia) and multiple-dose study in subjects with amyotrophic lateral sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria for Parts 1 and 2:
- •1. Healthy male or female aged between 18 to 65 years old at screening (inclusive)
- •2. For male and female subjects of childbearing potential: Subjects and their spouse/partners who are of childbearing potential must use highly effective contraception when engaging in sexual activity consisting of 2 forms of birth control (1 of which must be a barrier method such as latex or polyurethane condoms) starting at screening and continue throughout the clinical study period, and for 90 days after the final study drug administration.
- •3. For males: Subject must not donate sperm starting at screening and throughout the clinical study period, and for 90 days after the final study drug administration.
- •Inclusion criteria for Part 3:
- •1. Diagnosis of laboratory-supported probable, probable, or definite (sporadic) amyotrophic lateral sclerosis (ALS) according to the El Escorial World Federation of Neurology revised research diagnostic criteria (Ludolph et al. 2015)
- •2. Aged between 18 and 80 years old
- •3. 5 years or less since the onset of ALS symptoms
- •4. Forced vital capacity (FVC) =50% predicted value
- •5. Able to swallow medication for the duration of the study (in the opinion of the investigator)
排除标准
- •Exclusion criteria for Parts 1 and 2:
- •1. History of clinically significant hematological, renal, neurologic, pancreatic, gastrointestinal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, immunological, allergic disease, or other major disorders
- •2. Current significant medical or psychiatric condition
- •3. Evidence of clinically significant hepatic or renal impairment in the opinion of the investigator, including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 the upper limit of normal (ULN) or bilirubin > 1.5ULN. Patients with Gilbert syndrome without evidence of hepatic impairment may be enrolled.
- •4. Poor peripheral venous access
- •5. A lifetime history of suicidal behavior or suicidal ideation as determined by a positive response (‘’Yes’’) to either question 4 or question 5 of the C-SSRS at screening
- •6. For part 2 only: Subjects not eligible for lumbar puncture (anti-coagulation, anti-aggregation or blood coagulation pathologies, recent spine surgery, acquired or congenital spine malformation, clinical signs of intracranial hypertension, cutaneous infection at the punction site)
- •Exclusion criteria for Part 3:
- •1. Amyotrophic lateral sclerosis (ALS) patients with a known mutation in the SOD1 or C9orf72 gene
- •2. Tracheotomy and/or ventilator-dependent (or daily use of non-invasive ventilation = 22 hours for 7 consecutive days)
- •3. After percutaneous gastrostomy (PEG) operation
- •4. Subjects not eligible for lumbar puncture (anti-coagulation, anti-aggregation or blood coagulation pathologies, recent spine surgery, acquired or congenital spine malformation, clinical signs of intracranial hypertension, cutaneous infection at the punction site)
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