NCT07153172招募中1 期
Safety Follow-up Study of Participants Previously Dosed With INV-347 in the First-in-Human Study INV-CL-108
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Number of adverse events
研究概览
简要总结
The study looks at the safety and blood levels of the study drug INV-347 in participants who were previously dosed with INV-347 in study INV-CL-108. Participants will not get any study drug in this study as it looks into the safety of a drug previously dosed. The study will last until visit 21.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male or female (sex at birth).
- •Age 18 years or above at the time of signing the informed consent.
- •Previously dosed with INV-347 in study INV-CL-108 and with measurable INV-347 concentration in plasma at enrolment [above lower limit of qualification (LLOQ) of 0.5 nanogram per milliliter (ng/mL)].
排除标准
- •The study has no exclusion criteria.
研究组 & 干预措施
Participants from the study INV-CL-108
Experimental
Participants who were dosed with INV-347 in the First In Human study INV-CL-108 and still have measurable plasma exposure of INV-347 are included to assess long term safety.
干预措施: INV-347 (Drug)
结局指标
主要结局
Number of adverse events
时间窗: From the end-of-study participation in INV-CL-108 (week 0) to completion of the end-of-study visit (up to week 104 from enrolment)
Number of events
次要结局
未报告次要终点
研究者
研究点 (2)
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