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RECRUITING
NCT07295496
PHASE1

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

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China