Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy Adults

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.