NCT07701083进行中（未招募）1 期
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Two Eloralintide Solutions in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide
研究概览
简要总结
The main purpose of this study is to learn about safety, tolerability and how well the body processes two different eloralintide solutions. Participation in this study will last about 13 weeks, including screening, inpatient treatment, and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Are overtly healthy as determined by medical evaluation
- •Have a body mass index (BMI) within the range of 20.0 to 32.0 kilogram per square meter (kg/m2), inclusive
排除标准
- •Have known allergies to related compounds of eloralintide, or any of the components of the formulations
- •Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
- •Have been diagnosed with Type 1 or Type 2 diabetes mellitus, or have glycated hemoglobin greater than or equal to 6.5% or 48 millimole per mole (mmol/mol)
- •Have a history of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- •Have a history or presence of a gastrointestinal (GI) disorder or previous surgery that impacts gastric emptying for example, gastric bypass surgery or pyloric stenosis
- •Have obesity induced by other endocrinologic disorders for example, Cushing syndrome, or diagnosed monogenetic or syndromic forms of obesity for example, Melanocortin 4 Receptor deficiency or Prader Willi syndrome
- •Have taken approved or investigational medication for weight loss, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), within the previous 3 months of study screening
- •Intend to use any weight loss medications during study participation
研究组 & 干预措施
Eloralintide (Test)
Experimental
Participants will receive eloralintide test formulation administered SC.
干预措施: Eloralintide (Drug)
Eloralintide (Reference)
Active Comparator
Participants will receive eloralintide reference formulation administered subcutaneously (SC).
干预措施: Eloralintide (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide
时间窗: Predose on Day 1 through Day 57
PK: Maximum Concentration (Cmax) of Eloralintide
时间窗: Predose on Day 1 through Day 57
次要结局
未报告次要终点
研究者
研究点 (4)
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