An Open-Label Biomarker Study of BHV-1300 in Graves' Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 27
- 主要终点
- Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
研究概览
简要总结
The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers.
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
- •1. Participants must have serologically confirmed Graves' Disease.
排除标准
- •History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within six weeks of the Baseline visit.
- •History of treatment with radioactive iodine or thyroid surgery.
研究组 & 干预措施
BHV-1300
干预措施: BHV-1300 (Drug)
结局指标
主要结局
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
时间窗: Baseline to Week 12
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation or deaths that are observed during the Open-label Treatment Phase (up to 12 weeks).
Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities
时间窗: Baseline to Week 12
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.
次要结局
未报告次要终点