Acute Gout Flare
Conditions
Keywords
acute gout flare
Brief summary
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)
Interventions
DRUGIBI3011
* Anti-IL-RAP humanised monoclonal antibody injection * 300 mg (2.0 mL)/vial * Administered in accordance with the study protocol * Single administration only
DRUGIBI3011 Placebo
* Anti-IL-RAP humanised monoclonal antibody placebo injection * 300 mg (2.0 mL)/vial * Administered in accordance with the study protocol * Single administration only
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects are eligible for the study if they meet all of the following Inclusion Criteria: 1. Age ≥18 years of age, male or female; 2. 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 3. Meet ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout; 4. Other inclusion criteria set by protocol
Exclusion criteria
Subjects meeting any of the following criteria are not eligible to attend this clinical study: 1. Difficulties in venous blood collection or a history of dizziness when encountering blood or needles; 2. Have received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior; 3. Have live or attenuated vaccination in the 3 months before randomization or plan to receive that during this trial; 4. Blood donation or blood loss of more than 400 mL within 8 weeks before the screening; 5. Have a history of severe infection, severe trauma, or major surgical procedures within 6 months before the screening; 6. History of malignancy; 7. Female during pregnancy or lactation; 8. Have a history of drug abuse, drug dependence, or a positive result in a drug screen within 12 months before the screening; 9. 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: 10. Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout); 11. Infection/septic arthritis, or other acute inflammatory arthritis; 12. Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 12 week | To investigate the safety characteristics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenic outcome | 12 week | The incidence of antidrug Antibody (ADA) and/or Neutralising antibodies (NAb) |
| AUC | 12 Week | Describing the Area Under Curve |
| Cmax | 12 Week | Describing the Maximum Serum Concentration of Drug |
| CL or CL/F | 12 Week | Describing the Clearance |
| V or V/F | 12 Week | Describing the Apparent Volume of Distribution |
| t1/2 | 12 Week | Describing the Half Life |
Countries
China
Outcome results
None listed