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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
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)
Official title: A Single-dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anti-IL-RAP Humanized Monoclonal Antibody Injection in Chinese Subjects
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2025-12-08
Completion Date
2026-06-07
Last Updated
2025-12-19
Healthy Volunteers
Yes
Conditions
Interventions
IBI3011
* Anti-IL-RAP humanised monoclonal antibody injection * 300 mg (2.0 mL)/vial * Administered in accordance with the study protocol * Single administration only
IBI3011 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
Locations (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China