A Phase I Randomized, Double-Blind, Placebo-Controlled, Multiple Oral Dose Trial to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IBI353 (Orismilast) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to Maximal Blood Concentration (Tmax) of IBI353 and its related metabolites.
研究概览
简要总结
This is a first in Chinese population study to evaluate the safety, tolerability, PK and PD of multiple dose of modified-release IBI353 administered orally in healthy subjects. The study enrolls 20 healthy subjects and consists of 1 week of screening, 3 weeks of treatment period and 1 week of safety follow up after completion of last dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or female 18 to 45 years of age at the time of consent
- •BMI of 19-27Kg/m2 and weight of 50-100kg (male) or 45-100kg (female)
- •Participants are in good health condition at screening stage based on past history, lab tests, EEG, physical examinations, and vital signs.
- •Must provide written informed consent, and in the investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements
排除标准
- •Subjects who have a medical history of liver, kidney, cardiovascular, nervous / mental, gastrointestinal, respiratory, urinary, endocrine system;
- •Subjects who have a history of relapse or chronic infection, or a history of acute infection treated by antibiotics within 3 months;
- •Subjects who have previously used PDE4 inhibitor dugs;
- •Subjects who have clinically significant abnormalities determined by vital signs, physical examination, and laboratory measurements;
- •Subjects who are not suitable for this trial due to other reasons In the investigator' opinion
研究组 & 干预措施
Placebo tablet
干预措施: placebo (Drug)
IBI353 (Orismilast) dose 2
干预措施: IBI353 (Orismilast) (Drug)
IBI353 (Orismilast) dose 1
干预措施: IBI353 (Orismilast) (Drug)
结局指标
主要结局
Time to Maximal Blood Concentration (Tmax) of IBI353 and its related metabolites.
时间窗: Baseline through Day 21
Maximal Concentration (Cmax) of IBI353 and its related metabolites.
时间窗: Baseline through Day 21
Area Under the Concentration Curve (AUC) of IBI353 and its related metabolites.
时间窗: Baseline through Day 21
Volume of Distribution (Vd/F) of IBI353 and its related metabolites.
时间窗: Baseline through Day 21
Half life time of IBI353 and its related metabolites.
时间窗: Baseline through Day 21
Clearance (CL/F) of IBI353 and its related metabolites.
时间窗: Baseline through Day 21
Accumulation Ratio of IBI353 and its related metabolites.
时间窗: Baseline through Day 21
次要结局
- Incidence of treatment-emergent adverse events (TEAEs), gastrointestinal AEs, and changes of vital signs, lab examinations, physical examinations, ECGs in healthy subjects after drug administration.(Baseline through Day 28)