A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HS-10374 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
研究概览
简要总结
The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-10374 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects between the ages of 18-45 years
- •Have no reproductive potential; or agree to use a highly effective method of contraception, and refrain from donating sperm or eggs during the study period and for at least 6 months after last dosing
- •Have signed the informed consent form approved by the IRB
排除标准
- •Have a clinically significant infection currently or within past 30 days, or have a history of active tuberculosis; or have positive screening test for infectious disease, including tuberculosis, viral hepatitis, AIDS and syphilis
- •Have a history of or current allergic disease
- •Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol or drugs of abuse
- •Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test result for nicotine
- •Clinically significant abnormal physical examination, vital signs, clinical laboratory values, ECGs or imaging tests
- •Pregnant or breastfeeding female subjects
- •Have received hormone-based contraceptives, drugs that prolong the QT interval, drugs that may cause drug interactions with investigational product, immunosuppressants, vaccines or other drugs within a specific period
研究组 & 干预措施
HS-10374
Single and multiple ascending doses of HS-10374 orally
干预措施: HS-10374 tablets (Drug)
Placebo
Single and multiple ascending doses of HS-10374-matched placebo orally
干预措施: HS-10374-matched placebo tablets (Drug)
结局指标
主要结局
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
时间窗: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with clinical laboratory abnormalities
时间窗: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.
Number of participants with abnormalities of vital signs
时间窗: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.
Number of participants with abnormalities of physical examination
时间窗: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Number of participants with abnormalities of electrocardiogram (ECG) parameters
时间窗: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
次要结局
- Cmax(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Tmax(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- AUC(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- t½(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- CL/F(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Vz/F(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Rac(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))