Rheumatoid arthritis
Conditions
Interventions
A:Single oral dose of methotrexate tablets
A:14 consecutive days of oral administration of MY004567 tablets, with a single methotrexate tablet given on day 13
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Fully informed and voluntarily signed the ICF prior to any study-specific procedures. (2) Healthy Chinese subjects aged 18 to 45 years (inclusive of upper and lower limits) at the time of signing the ICF. (3) Weight =50 kg for man and weight =45 kg for women with a body mass index (BMI) of 19 to 26 kg/m2 (inclusive of upper and lower limits) at screening. (4) Females of reproductive age must have a negative blood human chorionic gonadotropin (hCG) pregnancy test at screening; all subjects and their sexual partners agree to use a highly effective method of contraception during the trial and for at least 90 days after dosing (informed according to Appendix 1); male subjects agree not to donate sperm during the trial and for 90 days after dosing.
Exclusion criteria
Exclusion criteria: (1) Previous food or drug allergy that, in the judgment of the investigator, is not suitable for inclusion. (2) Women who are breastfeeding; women of reproductive age who have had menstrual disorders within 90 days prior to dosing; women of reproductive age who have had unprotected intercourse with a heterosexual partner within 28 days prior to dosing. (3) Participated in any drug clinical trial within 90 days prior to dosing, or the dosing date of this study is still within the washout period specified in the previous drug clinical trial. (4) Non-physiological blood loss = 200 mL (including trauma, blood collection, blood donation) within 60 days prior to dosing; or plan to donate blood during the trial or within 30 days after dosing. (5) Had a clinically significant illness within 90 days prior to dosing in the judgment of the investigator. (6) Have undergone major surgery within 60 days prior to dosing, or have undergone any surgery within 28 days prior to dosing. (7) Have had an infectious disease such as fever within 28 days prior to dosing. (8) Have used any medication (including prescription drugs and over-the-counter drugs) within 14 days prior to dosing. (9) Vaccinated within 1 month prior to dosing, or who plan to be vaccinated during the trial. (10) Those with a history of alcohol or drug abuse or dependence, or a history of drug use; or those who do not meet the requirements of a common drug screen at screening. (11) Those who have smoked an average of more than 5 cigarettes per day during the 3 months prior to screening, or who cannot stop using any tobacco products during the trial. (12) Vital signs meeting any of the following at screening (as determined by the clinician): systolic blood pressure in a sitting position 140 mmHg; diastolic blood pressure in a sitting position 90 mmHg; pulse/heart rate 100 beats/min; (13) Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or syphilis antibody; or positive and clinically significant T-SPOT judged by the investigator; or a previous history of herpes zoster. (14) Those have had clinically significant gastrointestinal, hepatic, or renal abnormalities known to or likely to interfere with drug intake, transport, absorption, distribution, metabolism, or excretion at screening. (15) In the judgement of the investigator, the presence of other factors that may affect the results of the study and interfere with their participation in the overall study process, including but not limited to other medical history (e.g., history of psychiatric disorder), vital signs, physical examination, abnormal electrocardiogram and/or clinical laboratory tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration;Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;Physical examination;Pregnancy test;12-lead electrocardiogram;Blood routine;Reticulocyte test;Blood Biochemistry;Coagulation function;Urine routine;Stool routine;Fecal Occult Blood Test;Adverse events; | — |
Countries
China
Contacts
Public ContactWei hu
The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed