Rheumatoid arthritis, ulcerative colitis, atopic dermatitis
Conditions
Interventions
Single dose group:On the first day of the study, according to the randomization table requirements, the subjects were given 600mg of ZL-82 tablet (8 cases) or placebo (2 cases).
Multiple-dose administration group 1:On the first to the tenth day of the study, the subjects were given 50mg ZL-82 tablet once daily as per the randomization schedule (8 cases) or placebo (2 cases).
Multiple-dose administration group 2:On the first to the tenth day of the study, the subjects were given 100mg ZL-82 tablet once daily as per the randomization schedule (8 cases) or placebo (2 cases).
Multiple-dose administration group 3:On the first to the tenth day of the study, the subjects were given 200mg ZL-82 tablet once daily as per the randomization schedule (8 cases) or placebo (2 cases).
Sponsors
PKUCare Luzhong Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Those who can understand the informed consent form, voluntarily participate in the trial and sign the informed consent form. 2) Male or female; aged between 18 and 50 years old (inclusive of 18 and 50 years old). 3) Male subjects with a body weight of >= 50 kg, female subjects with a body weight of >= 45 kg, with a body mass index (BMI) ranging from 19.0 to 26.0 kg/m^2, where BMI = weight (kg) / height2 (m^2), including boundary values. 4) The subjects can communicate well with the researchers and complete the trial in accordance with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: Present illness history, past medical history, and recent medication history: 1) Those with a history of severe systemic diseases (including cardiovascular, digestive, urinary, respiratory systems, etc.), mental illness, or drug dependence; 2) Those with a history of organic heart disease, heart failure, myocardial infarction, angina pectoris, torsades de pointes, ventricular tachycardia, long QT syndrome or symptoms of long QT syndrome (such as syncope, convulsions), or a family history (with genetic proof or close relatives who died suddenly due to heart disease at a young age); 3) Those whose results of physical examination, vital signs, laboratory tests and other related tests (such as anteroposterior chest X-ray examination, abdominal color Doppler ultrasound, blood pregnancy test, ANA test, interferon-? release test, 12-lead electrocardiogram examination, etc.) during the screening period or baseline period were abnormal and had clinical significance; 4) Those with a history of lipid metabolism disorders, such as familial hyperlipidemia, lipoid nephropathy, or patients with acute pancreatitis accompanied by hyperlipidemia; 5) Those with neurological/psychiatric, respiratory, cardiovascular, digestive, hematological and lymphatic, endocrine, musculoskeletal system diseases, liver and kidney insufficiency, or any other diseases or physiological conditions that may affect the trial results at the time of screening; 6) Individuals with an allergic constitution, or with a history of food, drug allergy or other allergic diseases (such as asthma, urticaria, eczema, etc.) that the researcher deems to have clinical significance; or those known to be allergic to JAK inhibitors or the excipients in the investigational drug; 7) Those who have suffered from a major disease with clinical significance or undergone major surgery within 3 months prior to screening; 8) Those who have had an acute illness within 2 weeks prior to screening; those with clinically significant infections within 3 months prior to screening (such as upper respiratory tract infection, nasopharyngitis, urinary tract infection, etc.); those with evidence of any infection within 7 days prior to screening (such as fever, cough, expectoration, headache, etc.); those with a history of herpes simplex infection or recurrent (>1 time) herpes zoster or disseminated herpes zoster; 9) Those with a history of difficulty in swallowing or any gastrointestinal system disease (or gastrointestinal resection, etc.) that affects drug absorption; 10) Those who have donated blood within 3 months prior to screening, or plan to donate blood during the course of this trial, or have received a blood transfusion or lost blood >= 200 mL within 4 weeks prior to the trial; 11) Those who have participated in four or more clinical trials as subjects within the past year; or those who have participated in any clinical trial as subjects within three months prior to this trial. 12) Those with a history of drug abuse within five years before screening or who have used drugs within three months before screening. 13) Those who have concurrently used strong inducers of liver metabolic enzymes (such as omeprazole, barbiturates, carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, sulfinpyrazone, roxithromycin, etc.) within four weeks (28 days) before screening; or those who have taken any known drugs that cause QT/QTc interval prolongation or have the risk of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events;Physical examination;Vital signs;12-lead electrocardiogram?;Clinical laboratory tests (complete blood count, blood biochemistry, urine routine, coagulation function); | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak time of drug;Peak concentration of drug;Area under the curve;biological half life period;Average length of stay in the body;Apparent volume of distribution;Clearance rate;Drug fluctuation;Accumulation Index;The phosphorylation level of STAT5 stimulated by IL-2 factor in peripheral blood T cells (CD3/CD4/CD8) and the changes of CD45, CD3, CD4, CD8, CD56, CD19, and CD16 in peripheral blood cells.;The baseline-corrected and placebo-corrected QTcF intervals (??QTcF) based on the Fridericia correction formula after drug administration;Baseline-corrected HR, QTcF, PR and QRS (?HR, ?QTcF, ?PR and ?QRS);Baseline correction, placebo correction HR, QTcF, PR and QRS (??HR, ??PR, ??QTcF and ??QRS);Classification outliers of QTcF, HR, PR and QRS;The incidence of abnormal T-wave morphology and U-wave changes occurring; | — |
Countries
China
Contacts
Public ContactJie Hou/Hong Wang
PKUCare Luzhong Hospital
Outcome results
None listed