A Randomized, Open-label,Single Dosing Clinical Trail to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128 in Chinese Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PK parameter: AUC
研究概览
简要总结
A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 18 and 50 years at screening;
- •Subjects with a Body Mass Index (BMI) between 18.0 (inclusive) and 28.0 kg/m2 (inclusive); and a total body weight ≥55kg (male） and 45kg (female)
- •Participants who are overtly healthy as determined by medical evaluation including medical history, laboratory tests, vital signs and standard 12 lead ECGs.
- •Subject is willing to participate and to Sign written informed consent form.
排除标准
- •Subjects with a history of hypersensitivities to investigational products, including drug allergies (caused by aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivities
- •Subjects with evidence or a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (except simple appendectomy or repair of hernia) that may influence drug absorption
- •Subjects with evidence or a history of clinically significant hepatic (including carrier of viral hepatitis), renal, neurologic, immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric (mood disorder, obsessive-compulsive disorder, etc.) diseases.
- •Subjects with a history or current have mental disease.
- •Subjects who have taken any medicine that may affect outcomes within 30 days before the first administration of the investigational product.
- •Subject who have taken IBI128 in other studies.
- •Subjects who have a history of acute arthiritis.
- •Pregnant women or breast-feeding women or men and women who has possibility of pregnancy.
- •Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator
研究组 & 干预措施
IBI128
IBI128 po. QD(Quaque Die)
干预措施: dose-5 group (Drug)
IBI128
IBI128 po. QD(Quaque Die)
干预措施: dose-1 group (Drug)
IBI128
IBI128 po. QD(Quaque Die)
干预措施: dose-2 group (Drug)
IBI128
IBI128 po. QD(Quaque Die)
干预措施: dose-4 group (Drug)
IBI128
IBI128 po. QD(Quaque Die)
干预措施: dose-3 group (Drug)
结局指标
主要结局
PK parameter: AUC
时间窗: Up to Day 8
Area under the concentration-time curve （AUC）of IBI128
PK parameter: Cmax
时间窗: Up to Day 8
Maximum plasma concentration(Cmax) of IBI128
PK parameter: Tmax
时间窗: Up to Day 8
Time to ahieve Cmax
PK parameter: T1/2
时间窗: Up to Day 8
The time that takes for the dlimination processes to reduce the plasma concentration of the drug in the body by 50%.
次要结局
- Tolerability parameter: SAE(Up to Day 8)
- Safety parameter: AE(Up to Day 8)
- PD parameter: serum UA (uric acid）(Up to Day 8)