Phase I Clinical Study of ZL-82 Tablets

Prior treatment

• Major surgery within the 3 months prior to the trial or planning to undergo surgery during the trial
• Acute illness within 2 weeks prior to trial
• Positive urine drug screen (including morphine, methamphetamine, ketamine, MDMA, THC)
• Have used any prescription drugs (JAK inhibitors, etc.) that may have an effect on the test drug within 2 weeks;
• Participate in clinical trials of other drugs or medical devices as subjects within 3 months
• Women who are pregnant or breastfeeding or women of childbearing age who have had unprotected sex with their partner within 14 days before the test;
• The subjects or their partners are unwilling to use non-drug contraceptive measures (such as total abstinence, condoms, IUDs, ligation, etc.) for contraception during the trial, or the subject and his partner has a pregnancy plan within 6 months of signing the informed consent;

Other illness

• Allergic constitution, such as those who are known to be allergic to two or more substances, or those who are known to be allergic to JAK inhibitors or to the excipients contained in the test drug
• Have any serious diseases such as cardiovascular system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumor, mental illness, etc.
• History of dysphagia or any gastrointestinal disease (or gastrointestinal resection, etc.) affecting drug absorption
• HIV antibody, Treponema pallidum antibody, hepatitis B surface antigen and hepatitis C antibody test are positive

Lab values

• ALT and/or AST\>1×ULN, TIB\>1×ULN, GGT\>1×ULN; Scr\>1×ULN

Other

• Systolic blood pressure\>140mmHg or diastolic blood pressure\>90mmHg during the screening period;
• Blood donation or blood loss ≥400mL within 3 months, or blood transfusion; blood donation or blood loss ≥200mL within 1 month;
• Have special requirements for diet or cannot comply with the unified diet and corresponding regulations of the research center
• Alcoholics (alcoholism refers to drinking 60-degree white wine ≥10.5L or red wine ≥3.5L per week for more than 5 years), drinking a lot of coffee-containing beverages (more than 8 cups per day, 1 cup = 250ml) or heavy smoking (average \> 20 sticks/day);
• 4 weeks (28 days) before enrollment, strong inducers of liver metabolic enzymes was limit. ( such as omeprazole, barbiturates, carbamazepine, aminoglutamine, griseofulvin, carbamazepine, Phenytoin, Gluter, Rifampicin, Sulfinpyrazone, Roxithromycin, etc. )
• Not suitable to participate in the trial according to the judgment of the investigator.

• Healthy subjects, regardless of gender, 18 to 45 years old (including 18 and 45 years old)
• The weighing of male subjects ≥ 50kg, female subjects ≥ 45kg, and a body mass index (BMI) between 19 and 25kg/m2 (including boundary values)
• The medical history, physical examination, laboratory examination items and various tests and tests related to the trial before enrollment were normal or abnormal without clinical significance, and the clinical research doctor judged that they were qualified.
• Be able to understand the informed consent form, voluntarily participate in the trial and sign the informed consent form