Phase
Condition
Gastrointestinal Diseases And Disorders
Treatment
ZL-82 200mg
ZL-82 600mg
ZL-82 450mg
Clinical Study ID
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy subjects, regardless of gender, 18 to 45 years old (including 18 and 45years 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 varioustests and tests related to the trial before enrollment were normal or abnormalwithout clinical significance, and the clinical research doctor judged that theywere qualified.
Be able to understand the informed consent form, voluntarily participate in thetrial and sign the informed consent form
Exclusion
Exclusion Criteria:
Allergic constitution, such as those who are known to be allergic to two or moresubstances, or those who are known to be allergic to JAK inhibitors or to theexcipients contained in the test drug
ALT and/or AST>1×ULN, TIB>1×ULN, GGT>1×ULN; Scr>1×ULN
Major surgery within the 3 months prior to the trial or planning to undergo surgeryduring the trial
Acute illness within 2 weeks prior to trial
Have any serious diseases such as cardiovascular system, digestive system, urinarysystem, 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 hepatitisC antibody test are positive
Positive urine drug screen (including morphine, methamphetamine, ketamine, MDMA,THC)
Systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg during thescreening period;
Blood donation or blood loss ≥400mL within 3 months, or blood transfusion; blooddonation or blood loss ≥200mL within 1 month;
Have special requirements for diet or cannot comply with the unified diet andcorresponding 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 > 20sticks/day);
Have used any prescription drugs (JAK inhibitors, etc.) that may have an effect onthe test drug within 2 weeks;
4 weeks (28 days) before enrollment, strong inducers of liver metabolic enzymes waslimit. ( such as omeprazole, barbiturates, carbamazepine, aminoglutamine,griseofulvin, carbamazepine, Phenytoin, Gluter, Rifampicin, Sulfinpyrazone,Roxithromycin, etc. )
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 hadunprotected 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 duringthe trial, or the subject and his partner has a pregnancy plan within 6 months ofsigning the informed consent;
Not suitable to participate in the trial according to the judgment of theinvestigator.
Study Design
Connect with a study center
Affiliated Hospital of Guizhou Medical University
Guizhou, GuiYang
ChinaSite Not Available
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