Actively Recruiting
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-12-19
64
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Body mass index (BMI) 18-26 kg/m2 for healthy subjects (Part A)
- Body mass index (BMI) 18-40 kg/m2 for subjects with acute gout flare (Part B)
- Meet ACR 2015 preliminary criteria for acute arthritis of primary gout (Part B)
- Other inclusion criteria set by protocol
You will not qualify if you...
- Difficulty with venous blood collection or history of dizziness with blood or needles
- Received an experimental agent within 1 month or 5 times half-life before this study
- Received live or attenuated vaccination within 3 months before randomization or plan to receive during trial
- Blood donation or loss of more than 400 mL within 8 weeks before screening
- History of severe infection, trauma, or major surgery within 6 months before screening
- History of malignancy
- Female during pregnancy or lactation
- History of drug abuse, dependence, or positive drug screen within 12 months before screening
- History of neuropsychiatric or other disease unsuitable for this trial
- Secondary gout (e.g., chemotherapy-induced or transplant-related) (Part B)
- Infection, septic arthritis, or other acute inflammatory arthritis (Part B)
- Other exclusion criteria set by protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
C
Chunmiao Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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