autoimmune diseases
Conditions
Interventions
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1)Voluntarily participated in this study and provided a signed and dated informed consent form; (2)Aged 18 to 55 years (inclusive) at the screening visit, male or female; (3)Male subjects must weigh no less than 50 kg, and female subjects no less than 45 kg. Body mass index (BMI) must be within the range of 18.5 to 28 kg/m² (inclusive); (4) For female subjects:a) Non-childbearing potential,defined as:Surgically sterilized (documented bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) at least 6 weeks prior to the screening visit; or Postmenopausal >=12months of amenorrhea prior to screening, confirmed by follicle-stimulating hormone [FSH] levels >=40 IU/L); or b) Childbearing potential, in which case the subject must:Be non-pregnant, non-lactating,agree to use non-pharmacological contraceptive methods from 30 days prior to dosing, throughout the study, and for 3 months after dosing,Have a negative human chorionic gonadotropin (hCG) test at screening and D-1,Not donate oocytes during this period; (5)For male subjects with female partners of childbearing potential :must agree to use non-pharmacological contraceptive methods from 14 days prior to dosing, throughout the study, and for 3 months after dosing;must not donate sperm during this period; (6)Willing and able to comply with protocol-defined visits, study treatments, laboratory tests, and other study-related procedures and requirements.
Exclusion criteria
Exclusion criteria: (1) Hypersensitivity to the investigational drug or its excipients, or a history of severe allergic reactions (including any food or drug allergies); (2)History or family history of psychiatric disorders, hereditary immunodeficiency disorders, or chronic/severe medical conditions affecting the central nervous, cardiovascular, hepatic, renal, pulmonary, gastrointestinal, metabolic, hematological, skeletal systems, or any other disease or physical condition deemed by the investigator to potentially interfere with the study or pose an unacceptable risk to the subject; (3)History of anatomical abnormalities of the gastrointestinal tract, or intestinal/abdominal surgery affecting the structure or function of the gastrointestinal tract; (4)Subjects with a history of gastrointestinal disorders (e.g., gastrointestinal bleeding, gastrointestinal perforation, gastroesophageal reflux disease , inflammatory bowel disease), or those currently presenting with clinically evident or clinically significant gastrointestinal conditions (e.g., cholelithiasis) or symptoms (such as nausea, vomiting, diarrhea), or individuals who have undergone major gastrointestinal surgery; (5)Subjects with unexplained diarrhea within 3 months prior to screening; (6)History of lymphoproliferative disorders, including X-linked lymphoproliferative disease , autoimmune lymphoproliferative syndrome, post-transplant lymphoproliferative disorder, and various lymphoid hematologic malignancies; (7)History of organ transplantation; (8)History of chronic or recurrent infectious diseases, systemic infections caused by fungal, parasitic, or mycotic pathogens, or other opportunistic infections; (9)Known history of active or latent tuberculosis, inadequately treated latent TB infection, or history of close contact with individuals diagnosed with TB; (10)History of severe bone or joint infection within 6 months prior to screening; severe infection (e.g., hospitalization for infection or parenteral antibiotic therapy for infection) within 3 months prior to screening; or herpes zoster (shingles) infection within 3 months prior to screening; (11)Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab); (12)Presence of any acute infection or any signs or symptoms of infection; (13)Presence of skin wounds, unhealed surgical/traumatic sites, severe mucosal ulceration, or incompletely healed fractures; or individuals at risk of gastrointestinal bleeding/perforation (e.g., active gastroduodenal ulcer, intestinal obstruction, ulcerative colitis, gastroesophageal varices, gastrointestinal perforation) occurring within 6 months prior to screening; (14)Clinically significant abnormalities in vital signs, physical examination, or protocol-specified laboratory tests; (15)Clinically significant abnormalities in 12-lead electrocardiogram (ECG), e.g., QTcF interval (Fridericia correction) >450 ms in males and >470 ms in females; (16)Serum creatinine clearance (Ccr) < 90 mL/min (calculated via the Cockcroft-Gault formula): Cockcroft-Gault formula:Creatinine clearance (mL/min) = [(140 - age) × weight (kg) × (0.85 for females)] / [72 × serum creatinine (mg/dL)] or Creatinine clearance (mL/min) = [(140 - age) × weight (kg) × (0.85 for females)] / [0.81 × serum creatinine (µmol/L); (17)Known or suspected history of substance abuse (e.g., morphine, methamphetamine, ketamine, MDMA, THC, cocaine),
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic; | — |
Countries
China
Contacts
Public ContactXueying Ding
Shanghai General Hospital
Outcome results
None listed