NCT04893239已完成1 期
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
研究概览
简要总结
This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to participate in the clinical trial
- •Able and willing to provide informed consent
- •Stable ostomy (no revisions in the last 6 months)
- •At least 19 years old
- •Medically stable, but may be on medications for chronic conditions
排除标准
- •Unable or unwilling to provide adequate informed consent
- •Non-English speakers
- •Clinically significant disease
- •Women who are pregnant, intending to become pregnant, or breastfeeding
- •Use of anti-diarrheal medicine
- •Suffer gastroparesis
- •Opioid use
研究组 & 干预措施
Cohort 1 LMN-201 Anti-toxin B VHH-1
Experimental
干预措施: LMN-201 Anti-toxin B VHH-1 (Biological)
Cohort 1 LMN-201 Anti-toxin B VHH-2
Experimental
干预措施: LMN-201 Anti-toxin B VHH-2 (Biological)
Cohort 1 LMN-201 Anti-toxin B VHH-3
Experimental
干预措施: LMN-201 Anti-toxin B VHH-3 (Biological)
Cohort 4 LMN-201 VHH 1, 2, 3
Experimental
干预措施: LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3 (Biological)
结局指标
主要结局
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
时间窗: Arrival (baseline), Predose (immediately before dosing), and up to 12 hours post dose.
Count of participants with the presence or absence of capsules and/or transit markers at each collection timepoint in ostomy fluid by visual observation.
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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