The Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of SAL0133 Tablets in Chinese Adult Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The rate of AE
研究概览
简要总结
To evaluate the safety and tolerance of single and multiple administrations of SAL0133 tablets in adult healthy subjects in China receptivity.
详细描述
This study was divided into two parts: Part A and Part B. Part A was single-center, randomized, double-blind, and placebo control, single-dose escalation study (SAD) was conducted to evaluate the safety, tolerability and pharmacokinetic characteristics of SAL0133 tablets after a single dose. Furthermore, food effect would be preliminarily evaluated the influence of the pharmacokinetic characteristics of SAL0133 tablets in Part A. Part B was a single-center, randomized, double-blind, placebo controlled, multiple-dose escalation study was conducted to evaluate the safety, tolerability and pharmacokinetic characteristics of SAL0133 tablets after multiple doses.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants have fully understood the trial's objectives, procedures, and potential adverse effects, and voluntarily signed informed consent form prior to the trial.
- •Healthy male or female adults aged 18 to 65 years (inclusive).The gender ratio shall be no less than one third.
- •Body weight ≥50 kg for male participants and ≥45 kg for female participants at screening, with a body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive; BMI = body weight ÷ height2).
- •No abnormalities or only slight abnormalities not clinically significant of tests/examinations (including physical examination, vital sign examination, blood routine, urine routine, blood biochemistry, coagulation function, five thyroid function tests, five pituitary function tests, serological virology, 12-lead electrocardiogram, normal chest position, abdominal B-ultrasound, etc) as judged by the investigator.
- •The subject or their partner had no pregnancy plans during the study period and within one month after the last administration of the study drug, and the subjects do not donate sperm or eggs (oocytes, oocytes) for reproductive or assisted reproductive purposes.
排除标准
- •Pregnant or lactating women, or women of child-bearing potential (WOCBP) with a positive pregnancy test at screening.
- •A history of clinically significant drug allergies or allergic diseases (such as asthma, urticaria, eczema).
- •Dermatitis, etc., or as determined by the investigator, it may or is clear to be effective against the research drug (including similar drugs and controls) or allergy to the medicine and any of its excipients. Clinically significant underlying liver diseases or medical history, including chronic hepatitis B, chronic hepatitis C, and alcohol liver disease and metabolism-related fatty liver disease, etc.
- •Fever symptom or active infection within one week before the first administration of the drug.
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or the total bilirubin (TBIL) is higher than the upper limit of the normal value (ULN) during screening.
- •Have undergone gastric surgery, vagotomy, intestinal resection or any other procedures that might interfere with the gastrointestinal tract surgical procedures for peristalsis, pH or absorption.
- •Have received active or attenuated vaccines within 4 weeks before screening. ·Any of the following drugs or treatments were used before the first administration.
- •Drug or drug abuse, alcohol abuse, smoking addiction or special diet, etc. Any one of the antibody results is positive: Hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, human immunodeficiency virus (HIV).
- •Have participated in clinical studies of other drugs and taken any clinical study drugs within 3 months prior to the screening.
- •Who have donated blood or lost ≥400 mL of blood, received blood transfusion or used blood products within 3 months prior to the screening.
- •There is any disease history or current illness that may affect the safety of the subjects or the in vivo process of the investigational drug, including but not limited to the central nervous system, cardiovascular system, digestive system, respiratory system and endocrine system, urinary system, blood system, immune system, psychiatry, metabolic disorders, and those who have undergone gastrointestinal surgery (Except for cauditis surgery), etc.
- •History of fainting from needles or blood, and it has been judged by the researcher to be of clinical significance.
- •Any other reason, the researcher determines that the subject is not suitable to participate in this study.
研究组 & 干预措施
SAD 50mg Fasting
6 subjects received active drug and 2 subjects received placebo once daily under fasting condition
干预措施: SAL0133 (Drug)
SAD 50mg Fasting
6 subjects received active drug and 2 subjects received placebo once daily under fasting condition
干预措施: SAL0133 placebo (Drug)
SAD 150mg Fasting
6 subjects received active drug and 2 subjects received placebo once daily under fasting condition
干预措施: SAL0133 (Drug)
SAD 150mg Fasting
6 subjects received active drug and 2 subjects received placebo once daily under fasting condition
干预措施: SAL0133 placebo (Drug)
SAD 300mg Fasting
6 subjects received active drug and 2 subjects received placebo once daily under fasting condition
干预措施: SAL0133 (Drug)
SAD 300mg Fasting
6 subjects received active drug and 2 subjects received placebo once daily under fasting condition
干预措施: SAL0133 placebo (Drug)
SAD 150mg Fed
6 subjects received active drug and 2 subjects received placebo once daily under fed condition
干预措施: SAL0133 (Drug)
SAD 150mg Fed
6 subjects received active drug and 2 subjects received placebo once daily under fed condition
干预措施: SAL0133 placebo (Drug)
SAD 300mg Fed
6 subjects received active drug and 2 subjects received placebo once daily under fed condition
干预措施: SAL0133 (Drug)
SAD 300mg Fed
6 subjects received active drug and 2 subjects received placebo once daily under fed condition
干预措施: SAL0133 placebo (Drug)
SAD 600mg Fed
6 subjects received active drug and 2 subjects received placebo once daily under fed condition
干预措施: SAL0133 (Drug)
SAD 600mg Fed
6 subjects received active drug and 2 subjects received placebo once daily under fed condition
干预措施: SAL0133 placebo (Drug)
MAD 150mg Fasting
6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition
干预措施: SAL0133 (Drug)
MAD 150mg Fasting
6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition
干预措施: SAL0133 placebo (Drug)
MAD 150mg Fed
6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition
干预措施: SAL0133 (Drug)
MAD 150mg Fed
6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition
干预措施: SAL0133 placebo (Drug)
MAD 300mg Fed
6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition
干预措施: SAL0133 (Drug)
MAD 300mg Fed
6 subjects received active drug and 2 subjects received placebo once daily for seven days under fasting condition
干预措施: SAL0133 placebo (Drug)
结局指标
主要结局
The rate of AE
时间窗: from Day 1 to Day 5 or Day 10
The rate of AE occurred in the whole study
The rate of SAE
时间窗: from Day 1 to Day 5 or Day 10
The rate of SAE occurred in the whole study
blood pressure
时间窗: from Day 1 to Day 5 or Day 10
the change (mmHg) of blood pressure including SBP and DBP in the whole study
次要结局
未报告次要终点