A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism (HI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of congenital hyperinsulinism
- •Duration of glucose levels less than 70mg/dL, by CGM, for an average of at least 120 minutes a day across baseline Days -3, -2, and -1 with no single duration less than 60 minutes on any of the baseline Days -3, -2, or -1, unless the subject received rescue treatment.
- •Can safely washout of background medications used to treat hyperinsulinism.
排除标准
- •Use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or β agonists that may affect glucose metabolism
- •Body Mass Index ≥ 35 kg/m2
- •Pregnant females, females planning to become pregnant during the course of the study, females who have delivered 3 months before screening, or breastfeeding
- •Male subjects who are planning a pregnancy with a female partner during the course of the study or within 4 months after administration of study drug.
研究组 & 干预措施
Cohort
XOMA 358 dose level A, dose level B, dose level C, and dose level D.
干预措施: Cohort 1 (Drug)
Cohort
XOMA 358 dose level A, dose level B, dose level C, and dose level D.
干预措施: Cohort 2 (Drug)
Cohort
XOMA 358 dose level A, dose level B, dose level C, and dose level D.
干预措施: Cohort 3 (Drug)
Cohort
XOMA 358 dose level A, dose level B, dose level C, and dose level D.
干预措施: Cohort 4 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: 42 days
Safety assessed by treatment-emergent adverse events
Change from baseline in glucose levels as measured using a continuous glucose monitor
时间窗: 42 days
Safety assessed by pre- and post-treatment measurements of vital signs and laboratory test results
Fasting and post prandial blood glucose levels
时间窗: 42 days
Assessment of blood glucose collected at time points specified in the protocol
次要结局
未报告次要终点