CTIS2023-503677-37-00招募中1 期
A Phase 2, open-label, multi-center, 2-stage sequential cohort, dose escalation study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of subcutaneous SAR442501 in pediatric participants with Achondroplasia - DRI16646
Sanofi-Aventis Recherche & Developpement0 个研究点目标入组 36 人开始时间: 2023年6月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
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
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Participants must have ACH with a confirmed mutation in the FGFR3 gene, Participants and/or parent(s) or legal representative must be willing and able to perform all the study procedures to the best of their physical ability., Parent(s) or legal representative capable of giving signed informed consent and participants capable of giving assent when applicable.
排除标准
- •Have hypochondroplasia (or the N540K mutation) or short stature condition other than ACH (eg, trisomy 21, pseudochondroplasia), Participants have received any dose of medications or investigational product, including human growth hormone, IGF-1, intended to affect participants' stature or body proportions between the completion of OBS16647 and enrollment (Week 0/Day 1/Visit 2)., Have a history of growth plate closure., Long bone fracture within 3 months of enrollment (Week 0/Day 1/Visit 2), Current evidence of corneal or retinal disorder/keratopathy., Participants have had a previous surgical intervention involving the foramen magnum (Stage 2 only)., Hyperphosphatemia
研究者
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