A Phase 1 Randomized,Double-Blind,Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1603 in Chinese Healthy Subjects
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
- Number of participants with treatment-emergent adverse events (TEAEs) following oral doses of ZSP1603 and placebo,separately.
研究概览
简要总结
The Primary objectives of this study are to evaluate the safety and tolerability of ZSP1603 and the Secondary objective is to estimate the pharmacokinetic (PK) parameters after orally administered once daily of ZSP1603.
详细描述
This is a Phase 1, double-blinded, placebo-controlled, single center study aimed at investigating the safety, tolerability and the pharmacokinetics of ZSP1603 on fasted condition.Up to 4 cohorts of 32 eligible participants totally are planned to be enrolled. This is a two-arm clinical trial that ZSP1603 and matching placebo will be orally administered once daily. Two subjects in the first cohort will be assigned in a opened fashion to receive 7.5mg of ZSP1603 while another three cohorts of volunteers will be randomly assigned in a blinded fashion to receive either a single dose of ZSP1603 or matching placebo in an ascending dose fashion. To monitor AEs,record abnormalities (Holter, 12-lead ECG, Vital signs, Physical examination, Clinical Laboratory), and detect the pharmacokinetics of ZSP1603.
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)
盲法说明
Triple(Participant, Investigator, Clinical Research Associate)
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
- •Subjects are required to meet the following criteria in order to be included in the trial:
- •Males and female subjects between 18-50 years (Both inclusive).
- •Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 19.0 ≤ BMI ≤ 26.0 kg/m2; BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
- •Males or females are without gestation plans or infertility, or females who are menopausal, otherwise must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
- •Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
- •Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
排除标准
- •Eligible subjects must not meet any of the following exclusion criteria:
- •History or presence of any clinical severe diseases (such as circulatory system, endocrine , neurologic, gastrointestinal, respiratory system, urogenital system, hematic, immune, psychiatric and metabolic abnormalities), or any other diseases that,in the Investigator's opinion,might interfere with the assessment or follow-up;
- •Known hypersensitivity and/or allergy to some drugs and food,especially for the composition that is similar to the investigative product;
- •Subjects who have received a surgery within 4 weeks prior to the test or who plan to perform a surgery during the study;
- •Use of any drugs or health care products (including herbs) within 14 days prior to screening.
- •Any drugs with known hepatic enzyme-inducing or inhibiting agents that may change the activity of CYP3A4 within 30 days prior to dosing (such as inducer - Barbituric , Carmazepin , Phenyltoin , Glucocorticoids , and Omeprazole ; Inhibitors - SSRI antidepressants , Cimitedin , Diltiazem , Macrolides , Nitroimidazoles , Sedative hypnotic , Verapamil , Fluoroquinolone , Anti - histamine ).
- •Participated in another clinical research study and received any other investigational products within 3 months prior to dosing.
- •Subjects who donated blood or bleeding profusely(≥ 200 mL), received blood transfusion or use of blood products in the 3 months preceding study screening.
- •Pregnancy or breastfeeding at screening and during the study. All female subjects of childbearing potential and their partners cannot use at least one reliable method of non-drug contraception during the study and until 6 months following the last dose of investigational product.
- •Subjects who have special dietary habit and inability to consume the food provided in the study;
- •Subjects who could not tolerate venipuncture;
- •Dysphagia of capsule;
- •Frequently drinks tea, coffee and/or caffeinated beverages(more than 8 cups, 1 cup =250 mL) per day ;
- •Daily consuming more than 5 cigarettes within 3 months prior to screening or cannot stop using any tobacco products during the trial.
- •Smoke or have grapefruit juice,any food or beverage that contains alcohol or xanthin (including chocolate, tea, coffee, cola, etc.) from 48 hours pre-dose to the last blood collection ;
- •Known history of alcohol abuse (defined as consumption of more than 14 units of alcohol per week: 1 unit=360 ml of beer,or the equivalent of 45 mL liquor with 40% alcohol content, or 150 ml of wine;)or take any product contains alcohol during the study.
- •Known history of drug abuse or subjects who have used soft drugs (e.g., marijuana) within 3 months prior to screening, or have taken hard drugs (such as cocaine, phencyclidine, etc.) within one year before screening.
- •Presence clinically significant abnormalities (based on the judgment of clinical research doctors) of vital signs (systolic pressure <90 mmHg or >140 mmHg; diastolic pressure <60 mmHg or >90 mmHg；HR <50 bpm or>100 bpm) or ECG (QTcB>450ms in males, or QTcB>480ms in females) or physical examination, clinical laboratory tests and imaging examination.
- •Subjects who may not complete the study for other reasons or should not be included in the study in the opinion of the Investigator.
研究组 & 干预措施
ZSP1603 (single dose)-7.5 mg (Cohort 1)
Subject adminsitered at a dose of ZSP1603 7.5 mg on day 1 under fasted condition.
干预措施: ZSP1603 7.5 mg (Drug)
ZSP1603 (single dose)-12.5mg (Cohort 2)
Subject adminsitered at a dose of ZSP1603 12.5 mg or placebo on day 1 under fasted condition.
Enrollment into Cohort 2 will begin upon assurance of safety for Cohort 1.
干预措施: ZSP1603 12.5 mg (Drug)
ZSP1603 (single dose)-12.5mg (Cohort 2)
Subject adminsitered at a dose of ZSP1603 12.5 mg or placebo on day 1 under fasted condition.
Enrollment into Cohort 2 will begin upon assurance of safety for Cohort 1.
干预措施: Placebo 12.5mg (Drug)
ZSP1603 (single dose)-25 mg (Cohort 3)
Subject adminsitered at a dose of ZSP1603 25 mg or placebo on day 1 under fasted condition.
Enrollment into Cohort 3 will begin upon assurance of safety for Cohort 2.
干预措施: ZSP1603 25 mg (Drug)
ZSP1603 (single dose)-25 mg (Cohort 3)
Subject adminsitered at a dose of ZSP1603 25 mg or placebo on day 1 under fasted condition.
Enrollment into Cohort 3 will begin upon assurance of safety for Cohort 2.
干预措施: Placebo 25mg (Drug)
ZSP1603 (single dose)-50 mg (Cohort 4)
Subject adminsitered at a dose of ZSP1603 50 mg or placebo on day 1 under fasted condition.
Enrollment into Cohort 4 will begin upon assurance of safety for Cohort 3.
干预措施: ZSP1603 50 mg (Drug)
ZSP1603 (single dose)-50 mg (Cohort 4)
Subject adminsitered at a dose of ZSP1603 50 mg or placebo on day 1 under fasted condition.
Enrollment into Cohort 4 will begin upon assurance of safety for Cohort 3.
干预措施: Placebo 50mg (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs) following oral doses of ZSP1603 and placebo,separately.
时间窗: At Day 6 post-dose.
Number of participants with TEAEs as assessed by CTCAE v5.0.
次要结局
- t1/2 of ZSP1603(Up to 6 days post-dose)
- CL/F of ZSP1603(Up to 6 days post-dose)
- AUClast（AUC0-t）of ZSP1603(Up to 6 days post-dose)
- AUC0-24 of ZSP1603(Up to 6 days post-dose)
- Cmax of ZSP1603(Up to 6 days post-dose)
- Tmax of ZSP1603(Up to 6 days post-dose)
- λz of ZSP1603(Up to 6 days post-dose)
- VD/F of ZSP1603(Up to 6 days post-dose)
- MRT of ZSP1603(Up to 6 days post-dose)