NL-OMON53626招募中不适用
A phase 1, randomized, placebo-controlled, double-blind, single center, multiple-dose, parallel trial evaluating the impact of apraglutide on gastric emptying of liquids in healthy subjects - Multiple-dose trial evaluating impact of apraglutide on gastric emptying
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- VectivBio AG
- 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
- 18 至 64（—）
入选标准
- •1. Signed and dated informed consent form (ICF) prior to any trial-mandated
- •2. Subject must be healthy, as determined by medical history, complete physical
- •examination (including vital signs) and safety laboratory tests (general
- •biochemistry, hematology, urinalysis) including negative tests for human
- •immunodeficiency virus (HIV), hepatitis A, hepatitis B, and hepatitis C
- •3. Male or female subjects aged from 18 to 45 years inclusive (gastric motility
- •decreases with age) at the time of signing the ICF
- •4. Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive
- •5. Women of childbearing potential having undergone bilateral tubal occlusion
- •or with vasectomized partner. To be considered sterilized or infertile, females
- •must have undergone surgical sterilization (bilateral tubectomy, hysterectomy,
- •or bilateral ovariectomy)
排除标准
- •1. Body weight less than 50.0 kg
- •2. History of clinically significant gastro-intestinal, hepatic,
- •bronchopulmonary, neurological, cardiovascular, endocrine, or allergic disease
- •3. Any clinically relevant abnormal laboratory test results that are not in
- •line with subject status of healthy subject
- •4. Allergy or sensitivity to acetaminophen
- •5. Known hypersensitivity to the investigational medicinal product (IMP), any
- •of their excipients or drugs of the same class
研究者
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