NCT07295496 A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011
| NCT ID | NCT07295496 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
| Condition | Acute Gout Flare |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2026-06-07 |
Trial Parameters
Eligibility Fast-Check
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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)
Eligibility Criteria
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 th