2025-525124-10-00招募中2 期
A Phase 2, Open-Label Long-Term Extension Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon Skipping to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Efficacy of Endosomal Escape Vehicle Phosphorodiamidate Morpholino Oligomer Platform Products (ELEVATE-LTE)
Entrada Therapeutics Inc.17 个研究点 分布在 4 个国家目标入组 56 人开始时间: 2026年8月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 17
研究概览
简要总结
To evaluate the long-term safety and tolerability of study drug in participants with Duchenne muscular dystrophy (DMD).
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide consent (if at age of majority) or assent (if a minor).
- •Participant completed clinical study ENTR-601-44-201 or ENTR-601-45-
- •Males who are sexually active with a female partner of childbearing potential must agree to use condoms during sexual intercourse.
排除标准
- •Any change from the applicable parent study eligibility criteria, including safety events during the parent study, that in the opinion of the investigator in consultation with the medical monitor and/or sponsor designee precludes safe use of study drug.
研究组 & 干预措施
ENTR-601-45
Test
干预措施: ENTR-601-45 (Drug)
ENTR-601-44
Test
干预措施: ENTR-601-44 (Drug)
研究者
Regulatory Affairs
Scientific
Entrada Therapeutics Inc.
研究点 (17)
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