Acute gout flare
Conditions
Interventions
Participants in Health Studies (Randomized Parallel Controlled Trials):Qualified healthy subjects were admitted to the study ward before administration and were randomly assigned in a 6:2 ratio to rec
Participants in the Acute Gout Attack Study (Single arm):All qualified subjects are planned to receive subcutaneous administration of IBI3011 to explore the safety, tolerability, PK characteristics an
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be included in this study: 1. Understand and sign the informed consent form; 2. Age >=18 years old, male or female; 3. The Body Mass Index (BMI) of the healthy subjects in Part A was >=18.0kg/m^2 and <=26.0kg/m^2; In Part B, the BMI of the subjects with acute gout attack was greater than or equal to 18.0kg/m^2 and less than or equal to 40.0kg/m^2. 4. The results of physical examination, vital sign examination, laboratory tests (blood routine, urine routine, blood biochemistry, etc.), 12-lead electrocardiogram, abdominal B-ultrasound, chest X-ray and other tests completed during the screening period are normal or abnormal and have no clinical significance (only for healthy subjects in Part A). 5. During the trial period and within 6 months after administration, there was no child-rearing plan and adequate contraceptive measures could be taken. Subjects with acute gout attacks participating in Part B of the study also need to meet the following criteria: 6. Conform to the 2015 gout classification diagnostic criteria of the American College of Rheumatology (ACR) (see Appendix 4); 7. There have been at least two previous episodes of gouty arthritis, and the pain in the target joint was completely relieved each time 8. An acute gout attack occurred within 4 days before administration (determined by the researcher based on the subject's symptoms, signs, chief complaint, medical records, etc.); 9. During the screening process, the VAS pain score (0-100mm) of the target joint for acute gout attack of the subjects was greater than or equal to 50mm.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are not eligible to attend this clinical study: 1. Have a history of specific allergies (such as asthma, urticaria, eczema, etc.) or hypersensitivity reactions to previous use of biological agents, or atopic diathesis (e.g., allergies to two or more types of drugs, foods, and pollen); 2. Difficulties in venous blood collection or history of dizziness when encountering blood or needles; 3. Have received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior; 4. Have live or attenuated vaccination in the 3 months prior to randomization or plan to receive that during the this trial; 5. Blood donation or blood loss of more than 400 mL within 8 weeks before the screening; 6. Have a history of severe infection, severe trauma, or major surgical procedures within 6 months before the screening; 7. Have infection requiring systemic therapy within 30 days before randomization or has persistent infection before the screening; 8. Unable to receive intramuscular injection, such as current anticoagulation therapy, thrombocytopenia, or diseases with a risk of thrombocytopenia, such as aplastic anemia, hypersplenism, or known hemorrhagic diseases like idiopathic thrombocytopenic purpura or hemophilia, or chronic periodontal disease; 9. History of malignancy; 10. Female during pregnancy or lactation; 11. Female (or male) of child-bearing potential has childbearing (or sperm donation) plan or reject to use effective contraceptive methods from the screening period to 6 months after the last dose of the investigational product; 12. Consume more than 2 units of alcohol per day on average within 3 months before screening, or drinking before the drug administration, or reject quit drinking during this trial, or has a positive alcohol breath test (only for Part A healthy subjects); 13. Have a history of drug abuse, drug dependence, or a positive result in drug screen within 12 months before the screening; 14. Positive screening test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody; 15. Have a history of prolonged QT interval, or QTc > 450ms for males and > 470ms for females during the screening; 16. For Part A healthy subjects: have clinical or radiological evidence indicated active tuberculosis (TB) or latent tuberculosis infection (LTBI) phase; For Part B acute gout flare subjects: were diagnosis as tuberculosis or have risk factors for tuberculosis, including but not limited to: a) Taking Antibacterial drugs, such as isoniazid; b) Had close contact with active pulmonary tuberculosis patients within the last 12 months; c) Have highly suspected or confirmed active tuberculosis infection; 17. Have the medical history (including past and present) of other significant diseases, including but not limited to pulmonary, cardiovascular, gastrointestinal, hematological, endocrinological and metabolic disease, immunological, dermatological, malignant diseases, mental and nervous systems, and other related diseases (only for Part A healthy subjects); 18. Has a history of neuropsychiatry or any other disease/ailment that unsuitable for this clinical trial at the discretion of the Investigator; Part B acute gout flare subjects also needed to exclude the following criteria: 19. Received following drugs or therapy within the specified time before to the drug administration: a) Glucocortic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters, Including: Area Under the Plasma Concentration-Time Curve (AUC, including AUC from time zero to infinity, AUC?-8), Maximum Plasma Concentration (Cmax), Clearance (CL), Volume of Distribution (Vd), Terminal Elimination Half-life (t?/?), as well as Time to Reach Maximum Concentration (tmax) and Elimination Constant (Kel) if needed.;The incidence of antidrug Antibody (ADA) and/or Neutralising antibodies (NAb); | — |
Countries
China
Contacts
Public ContactLiyan Miao, Jian Wu
The First Affiliated Hospital of Soochow University
Outcome results
None listed