Systemic Lupus Erythematosus
Conditions
Interventions
A:Single oral administration (dose 1)
B:Single oral administration (dose 2)
C:Single oral administration (dose 3)
D:Single oral administration (dose 4)
E:Single oral administration (dose 5)
F:Single oral administration (dose 6)
G:Multiple oral administrations (dose 1)
H:Multiple oral administrations (dose 2)
I:Multiple oral administrations (dose 3)
J:Multiple titration administration (dose 1)
FE-A:period 1: fasting state, period 2: fed state
FE-B:period 1: fed state, period 2: fasting state
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult volunteers aged 18 to 45 (including 18 and 45 years). 2. Weight=50 kg for males,=45 kg for females, BMI 19-26 kg/m2. 3. Medical history screening, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory findings are normal or abnormal as determined by the investigator to be not clinically significant. 4. Heart Rate of ECG during screening period was 60~100 bpm (including 60 and 100 bpm). 5. Sign informed consent before the trial and fully understand the trial's contents, process, and possible adverse reactions. Voluntary participation and ability to complete trials as required. 6. The subjects did not receive live attenuated vaccine, inactivated vaccine or toxoid 1 month before the clinical trial, and agreed not to receive live attenuated vaccine, inactivated vaccine or toxoid during the trial and within 3 months after the last administration. 7. The subjects and their female partners are willing to use the screening before 2 weeks to test drugs within 6 months after the last delivery without family planning and voluntarily to take effective contraceptive measures and no donor program, and ensure the 2 weeks to test before use drug 1 month after the last dose of sex with one or more than one nondrug contraception.
Exclusion criteria
Exclusion criteria: 1. Female subjects who have tested positive for pregnancy at screening or baseline period or who are breastfeeding. 2. Medical history or ongoing diseases with abnormal clinical manifestations that need to be excluded, including but not limited to cardiovascular, respiratory, endocrine, metabolic, renal, hepatic, digestive, dermatological, infectious, macular oedema and other ophthalmic abnormalities, malignancies, hematological, neurological or psychiatric disorders. 3. History of acute or chronic bronchospasm (including asthma and chronic obstructive pulmonary disease, etc.). 4. Myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or NYHA class III or IV heart failure within 6 months prior to screening. 5. The subjects with abnormal and clinically significant ECG examinations in screening period, or PR > 200ms, or ECG abnormalities such as second degree AV block, sick sinus syndrome, sinus AV block, or subjects with ventricular tachyarrhythmias in screening period or a previous history of this condition. 6. ECG examination in screening period, men: QTcF > 450ms, women: QTcF > 470ms (corrected by Fridericia's formula). 7. The subjects with a history of unstable vascular disease, a history of syncope with hypotension within the last 2 years, a history of upright hypotension, or a history of tachycardia or hypertension. 8. In screening period, systolic blood pressure <90 mmHg or =140 mmHg and diastolic blood pressure <60 mmHg or =90 mmHg. 9. A routine blood test in screening period: the white blood cell count, lymphocyte count and neutrophil count are either below the lower limit of normal or above the upper limit of normal and judged by the investigator to be clinically significant. 10. A known history of recurrent or chronic infection within 3 months prior to screening, including but not limited to chronic urinary tract infections such as recurrent urinary tract infections, chronic respiratory tract infections such as bronchiectasis, chronic sinusitis, etc., skin soft tissue infections such as open drains or infected skin wounds, etc.; or an acute infection within 7 days prior to screening may affect this clinical trial judged by the investigator, including but not limited to respiratory infections, infectious diarrhea, etc., or concomitant medication. 11. Subjects who are positive for any of HIV antibody, syphilis spirochete antibody, HCV antibody, hepatitis A virus antibody or hepatitis B virus surface antigen. 12. Subjects with a history of substance abuse or drug use within 6 months prior to screening. 13. Enrolled in other drug clinical trials and received clinical trial drugs within 3 months prior to screening. 14. Blood donations including component blood or significant blood loss (=400 mL) within 3 months prior to screening, or planned to donate blood during the trial. 15. Any definite history of allergy to drugs or food, etc., especially allergic or hypersensitive to ingredients similar to this test drug. 16. Those who cannot tolerate venipuncture or have a history of needle sickness or blood sickness. 17. Those with swallowing difficulties. 18. Those who have used any medication, including prescription drugs, over-the-counter drugs, herbal medicines and vitamins, within 2 weeks or within 7 drug half-lives (whichever is longer) prior to screening. 19. Average weekly alcohol consumption greater than 14 units (1 unit of alcohol ˜ 360
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;adverse event;vital signs;laboratory inspection;12 lead electrocardiogram;Lymphocyte count in peripheral blood;Percentage of lymphocytes; | — |
Countries
China
Contacts
Public ContactWei hu
Drug Clinical Trial Research Center, The Second Hospital of Anhui Medical University
Outcome results
None listed