Health subjects
Conditions
Interventions
Queue A:Group A subjects took KL130008 capsules orally on an empty stomach (new prescription/old prescription)
Queue B:The subjects of Group B took KL130008 capsules orally on an empty stomach (new prescription/old prescription)
Queue c:The subjects in Group C took KL130008 capsules orally (new prescription) on an empty stomach/after-meal state
Queue D:The subjects of Group D took KL130008 capsules orally (new prescription) in the post-meal/fasting state
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be selected: 1) The age of signing the informed consent form is = 18 years old and = 55 years old, regardless of gender; 2) Male subjects weighed = 50.0 kg, female subjects weighed = 45.0 kg, and 18.5 kg/m2= body mass index [BMI = weight (kg)/height 2 (m2)]= 25.0 kg/m2; 3) During the study period and within 3 months after the last administration, fertile subjects (both men and women) must take effective medical contraception (see the attachment for specific contraceptive measures); 4) Subjects voluntarily joined the study, signed an informed consent form, and were able to follow the visitation and related procedures stipulated in the program.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded: 1) Those who are known to have a history of allergic reactions to any ingredient and/or other similar products of the study drug; 2) Those with mental or neurological diseases who cannot fully understand and cooperate; 3) People with a history of malignant tumors; 4) Previously, there was a history of recurrent herpes zoster, herpes simplex, or herpes zoster or herpes simplex in the first 3 months; 5) Those who have a history of recurrent chronic infections in the past, or have had any infections that have been determined to be clinically significant by researchers within the first 3 months of randomization; 6) Those who have a history of tuberculosis (TB) but have not recovered from standardized anti-tuberculosis treatment, or those with a history of close contact with active tuberculosis, or those diagnosed as suspected/confirmed tuberculosis through a medical history, physical examination or related examination; 7) Previously suffering from severe or poorly controlled systemic diseases (such as severe liver damage, interstitial pulmonary disease); randomized first month and screening period with unstable/decompensated cardiopulmonary function, intestinal arous syndrome, ulcerative colitis and other diseases that cause chronic gastrointestinal dysfunction; 8) Previously suffering from serious blood system diseases (such as aplastic anemia, myelodysplastic syndrome, etc.), or any disease that can cause hemolysis or erythrocyte instability (such as malaria, hemolytic anemia, etc.) in the first three months of randomization; 9) Have a history of dysphagia or any gastrointestinal disease that may affect drug absorption; 10) Heart failure (NYHA standard grade II~IV), unstable angina pectoris, myocardial infarction, persistent and clinically significant arrhythmias, and obvious extension of QTcF intervals (male >450 ms for men and women >470 ms; according to Frider Icias formula correction), and/or those who believe that there is an additional risk to the research drug, such as stroke and transient ischemia; 11) In the absence of drugs affecting blood pressure during the screening period: systolic blood pressure 140 mmHg and/or diastolic blood pressure >90 mmHg, and the researchers judged to be clinically significant; 12) Those who are hepatitis B surface antigen-positive, or hepatitis B virus DNA detection is higher than normal when the surface antigen is negative and hepatitis B core antibody is positive; hepatitis C antibody positive; HIV antibody positive; syphilis antibody test positive; 13) People with a history of drug abuse; those who have tested positive for random pre-drug abuse; 14) Those who meet the following criteria during the screening period and are judged to be clinically significant by the researchers: A) Hematopoietic function: neutrophil count upper limit of normal value (ULN), lymphocyte count ULN, hemoglobin URN, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>ULN; C) Kidney function: urea (Urea) > URN and/or blood creatinine (Cr) > URN; D) Coagulation function: International Standardized Ratio (INR) > URN, Activated Partial T
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tmax;Cmax;Cmax;?z;t?;CL/F;Vz/F;AUC0-t; | — |
Countries
china
Contacts
Public ContactPing Feng
West China Hospital of Sichuan University
Outcome results
None listed