A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011

Inclusion criteria

Subjects are eligible for the study if they meet all of the following Inclusion Criteria:

• Age ≥18 years of age, male or female;
• Body mass index (BMI) 18-26 kg/m2 (inclusive) for Part A healthy subjects and BMI 18-40 kg/m2 (inclusive) for Part B acute gout flare subjects; Part B acute gout flare subjects also needed to meet the following criteria
• Meet ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout;
• Other inclusion criteria set by protocol

Exclusion criteria

Subjects meeting any of the following criteria are not eligible to attend this clinical study:

• Difficulties in venous blood collection or a history of dizziness when encountering blood or needles;
• Have received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior;
• Have live or attenuated vaccination in the 3 months before randomization or plan to receive that during this trial;
• Blood donation or blood loss of more than 400 mL within 8 weeks before the screening;
• Have a history of severe infection, severe trauma, or major surgical procedures within 6 months before the screening;
• History of malignancy;
• Female during pregnancy or lactation;
• Have a history of drug abuse, drug dependence, or a positive result in a drug screen within 12 months before the screening;
• Has a history of neuropsychiatry or any other disease/ailment that is unsuitable for this clinical trial at the discretion of the Investigator;

Part B acute gout flare subjects also needed to exclude the following criteria:

• Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout);
• Infection/septic arthritis, or other acute inflammatory arthritis;
• Other exclusion criteria set by protocol