Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanised monoclonal antibody injection in healthy Chinese subjects (Part A) and subjects with acute gout flare (Part B)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | IBI3011 placebo group |
|
| IBI3011 | Active Comparator | IBI3011 group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI3011 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | To investigate the safety characteristics. | 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenic outcome | The incidence of antidrug Antibody (ADA) and/or Neutralising antibodies (NAb) | 12 week |
| AUC | Describing the Area Under Curve |
Not provided
Inclusion Criteria:
Subjects are eligible for the study if they meet all of the following Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| IBI3011 Placebo | Drug |
|
|
| 12 Week |
| Cmax | Describing the Maximum Serum Concentration of Drug | 12 Week |
| CL or CL/F | Describing the Clearance | 12 Week |
| V or V/F | Describing the Apparent Volume of Distribution | 12 Week |
| t1/2 | Describing the Half Life | 12 Week |