A Single-dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anti-IL-RAP Humanized Monoclonal Antibody Injection in Chinese Subjects
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: t
View:
⁃ Subjects are eligible for the study if they meet all of the following Inclusion Criteria:
• Age ≥18 years of age, male or female;
• 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
• Meet ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout;
• Other inclusion criteria set by protocol
Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Chunmiao Li
chunmiao.li@innoventbio.com
0512-69566088
Time Frame
Start Date: 2025-12-08
Estimated Completion Date: 2026-06-07
Participants
Target number of participants: 64
Treatments
Placebo_comparator: Placebo
IBI3011 placebo group
Active_comparator: IBI3011
IBI3011 group
Sponsors
Leads: Innovent Biologics (Suzhou) Co. Ltd.