NCT05791201进行中（未招募）1 期
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-264 in Subjects With Type 1 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 7
- 试验地点
- 24
- 主要终点
- Part A and Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).
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
- •Clinical history of T1D with greater than or equal to (>=) 5 years duration Participant is on a stable diabetic treatment Consistent use of continuous glucose monitoring (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study
排除标准
- •Prior islet cell transplant, organ transplant, or cell therapy
研究组 & 干预措施
VX-264
Experimental
干预措施: VX-264 (Drug)
结局指标
主要结局
Part A and Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From Day 1 up to 24 months
Part B and Part C: Change in Peak C-peptide during Mixed-Meal Tolerance Test (MMTT)
时间窗: From Baseline and at Day 90
次要结局
- Part C: Proportion of Participants who are Insulin Independent at One Point in Time(From Day 180 up to Day 365)
- Part C: Change in HbA1c values(From Baseline up to 24 months)
- Part C: Change in Average Total Daily Insulin Dose(From Baseline up to 24 months)
- Part C: Change in peak C-peptide during MMTT(From Baseline up to 24 months)
研究者
研究点 (24)
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