RecruitingPhase 1

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

China64 participantsStarted 2025-12-08

Plain-language 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)

Who can participate

Age range18 Years – 100 Years

SexALL

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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

Exclusion criteria

✕. Difficulties in venous blood collection or a history of dizziness when encountering blood or needles;
✕. Have received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior;
✕. Have live or attenuated vaccination in the 3 months before randomization or plan to receive that during this trial;
✕. Blood donation or blood loss of more than 400 mL within 8 weeks before the screening;
✕. Have a history of severe infection, severe trauma, or major surgical procedures within 6 months before the screening;
✕. History of malignancy;
✕. Female during pregnancy or lactation;
✕. Have a history of drug abuse, drug dependence, or a positive result in a drug screen within 12 months before the screening;

What they're measuring

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: 12 week

Trial details

NCT IDNCT07295496

SponsorInnovent Biologics (Suzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-07

Contact for this trial

Chunmiao Li

0512-69566088 chunmiao.li@innoventbio.com

View on ClinicalTrials.gov More Acute Gout Flare trials