NCT07295496

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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)

Conditions

• Acute Gout Flare

Interventions

Type	Name	Description
DRUG	IBI3011	* Anti-IL-RAP humanised monoclonal antibody injection * 300 mg (2.0 mL)/vial * Administered in accordance with the study protocol * Single administration only
DRUG	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

Timeline

• Start date: 2025-12-08
• Primary completion: 2026-06-07
• Completion: 2026-06-07
• First posted: 2025-12-19
• Last updated: 2025-12-19

Locations

1 site across 1 country: China