NCT05012761已完成1 期
A Phase I Bridging Study to Evaluate the PK, Safety and Tolerability of SR419 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rac
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate the PK, safety and tolerability of SR419 in healthy subjects.
详细描述
The study is a Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy volunteers. The study will include 3 single-ascending-dose (SAD) cohorts and 2 multiple-dose cohorts (Part A and part B respectively), a total of 5 cohorts, and each cohort includes 3 stages: screening and baseline, treatment and safety monitoring, and safety follow-up.
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
- Triple (Participant, Care Provider, 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 males and females who are 18 to 45 years of age.
- •Based on medical history, physical examination, laboratory examination, chest X-ray, abdominal B-ultrasound, vital signs and ECG, the investigator considered that the results were normal or abnormal but no clinical significance.
- •Bodyweight of male > 50 kg, Bodyweight of female > 45 kg and body mass index (BMI) between 18 and28 kg/m2
- •Male subjects must agree to use contraception methods.
- •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
排除标准
- •Clinically significant history of central nervous system (CNS) disease, such as cognitive disorder and seizures. History of non-clinically significant mild anxiety (related to social stressors) or situational sleep disturbance > 6 months ago could be enrolled under the discretion of the Investigators.
- •Known history of renal dysfunction or creatinine clearance < 90 mL/min (calculated using the Cockcroft-Gault formula) at Screening.
- •Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- •History of regular alcohol consumption within 6 months of screening defined as: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~285 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
- •History of significant drug abuse within one year of screening or use of soft drugs (such as marijuana) within 3 months prior to screening or hard drugs (such as cocaine, methamphetamine, crack) within 1 year prior to screening.
- •History of sensitivity to any of the investigational medicinal products (IMPs), or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation.
- •History of asthma (excluding resolved childhood asthma), severe allergic responses.
- •History of hypercoagulable state or history of thrombosis.
- •A positive Hepatitis B surface antigen, positive Hepatitis C antibody and positive test for human immunodeficiency virus (HIV) antibody.
- •within 6 months of screening, Smoking more than 4 cigarettes per day (including e-cigarettes).
- •A positive drug/alcohol result at Screening or Day -
- •Donation or lost in excess of 500 mL of blood within 56 days of Day 1 or donation of plasma within 14 days of Day
- •The subject has participated in a clinical trial within 3 months of receiving IMP.
- •Use of medication other than topical products without significant systemic absorption.
- •Unable to refrain from consumption of Seville oranges, grapefruit or grapefruit juice within 24h prior to the first dose of IMP until the Safety Follow-up visit.
- •Unable to refrain from consumption of alcohol, products containing caffeine or xanthine (such as coffee, tea, cola, chocolate) within 7 days prior to the first dose of IMP until the Safety Follow-up visit.
- •Breast-feeding and/or lactating subject.
- •Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
研究组 & 干预措施
SR419 capsules
Experimental
Ascending single and multiple doses of SR419 orally
干预措施: SR419 capsules (Drug)
Placebo
Placebo Comparator
Ascending single and multiple doses of SR419 placebo orally
干预措施: Placebo (Drug)
结局指标
主要结局
Rac
时间窗: Up to Day 7
Accumulation ratio
Tmax
时间窗: Up to Day 7
Time of peak plasma concentration
Cmax
时间窗: Up to Day 7
Peak plasma concentration
t1/2
时间窗: Up to Day 7
Terminal half-life
AUC
时间窗: Up to Day 7
Area under the plasma concentration-time curve
CL/F
时间窗: Up to Day 7
Apparent oral clearance
次要结局
- The frequency and severity of AEs in healthy volunteers administrated with single and repeated oral doses of SR419 capsules(Up to Day12(+7 days) for the safety follow up since Day1)
研究者
研究点 (1)
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