Safety and dosing of IBI3011 in healthy adults and people with acute gout flares

A Single-dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anti-IL-RAP Humanized Monoclonal Antibody Injection in Chinese Subjects

This study will test whether the antibody IBI3011 is safe and how it behaves in the body in healthy adults and in people experiencing an acute gout flare.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07295496 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional study tests a recombinant humanized monoclonal antibody (IBI3011) given by injection in two parts: Part A enrolls healthy Chinese adults and Part B enrolls adults with acute gout flares. Participants will receive IBI3011 or placebo and will be monitored for safety, tolerability, and pharmacokinetics. Key data collected include adverse events, vital signs, lab tests, and blood levels of the drug over time. The goal is to define safety and dosing behavior to inform later efficacy trials.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) willing to be treated at the study site: healthy volunteers with BMI 18–26 kg/m2 for Part A, or adults meeting ACR 2015 criteria for acute gout with BMI 18–40 kg/m2 for Part B.

Not a fit: People who recently received experimental drugs, recent live vaccines, have difficulty with blood draws, or who do not meet the ACR criteria for acute gout are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, IBI3011 could become a new targeted biologic option to reduce inflammation and pain during acute gout flares.

How similar studies have performed: Other biologic drugs targeting the IL-1 pathway (for example anakinra and canakinumab) have shown benefit for gout flares, but IBI3011 is a novel anti–IL-RAP antibody and remains less tested.

Eligibility criteria

Inclusion Criteria:

Subjects are eligible for the study if they meet all of the following Inclusion Criteria:

1. Age ≥18 years of age, male or female;
2. 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
3. Meet ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout;
4. Other inclusion criteria set by protocol

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible to attend this clinical study:

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

   Part B acute gout flare subjects also needed to exclude the following criteria:
10. Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout);
11. Infection/septic arthritis, or other acute inflammatory arthritis;
12. Other exclusion criteria set by protocol

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Chunmiao Li

Conditions Acute Gout Flare; acute gout flare