IDL-2965 - A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Incidence and severity of treatment emergent Adverse Events (AEs), AEs leading to discontinuation from Investigational Medicinal Product (IMP) or the study, serious adverse events (SAEs), and deaths.
研究概览
简要总结
The purpose of this study is to test the safety and tolerability of the drug candidate IDL-2965 and to see how it is absorbed, processed, and removed by the body.
详细描述
IDL-2965 is an oral integrin antagonist antifibrotic being studied as a potential treatment for IPF and Nonalcoholic Steatohepatitis (NASH). This double-blind, randomized, placebo-controlled, single and multiple oral dose study will be conducted in 3 parts. Part A will comprise a single-dose, sequential-group design in healthy subjects, incorporating a food-effect evaluation. Part B will consist of a multiple-dose, sequential-group design in healthy subjects. Part C will be a multiple-dose, sequential-group design in subjects with IPF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects:
- •Male and female subjects aged between 18 and 60 years, with a body mass index between 18.0 and 32.0 kg/m
- •IPF subjects:
- •Male and female subjects over 40 years of age.
- •Diagnosis of idiopathic pulmonary fibrosis
- •Idiopathic pulmonary fibrosis has been stable for at least 3 months.
排除标准
- •Healthy subjects and IPF subjects:
- •Significant history or clinical manifestation of any disease/disorder, other than IPF.
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound
- •Poor peripheral venous access
- •Use or intend to use any medications, tobacco or nicotine containing products or electronic cigarettes.
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- •IPF subjects:
- •Pulmonary function tests and other diagnostic procedures inconsistent with diagnosis of idiopathic pulmonary fibrosis.
研究组 & 干预措施
Placebo Oral Capsule
Placebo oral capsule, single and multiple doses
干预措施: Placebos (Drug)
IDL-2965 Oral Capsule
IDL-2965 oral capsule, single and multiple doses
干预措施: IDL-2965 Oral Capsule (Drug)
结局指标
主要结局
Incidence and severity of treatment emergent Adverse Events (AEs), AEs leading to discontinuation from Investigational Medicinal Product (IMP) or the study, serious adverse events (SAEs), and deaths.
时间窗: Single Ascending Dose (SAD): up to 7 Days/ Multiple Ascending Dose (MAD): up to 21 Days/ IPF MAD: up to 40 Days
Safety
次要结局
- Pharmacokinetic (PK)(SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 40 Days)