RecruitingPhase 1NCT07295496

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


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

64 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria3

  • 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;

Exclusion Criteria13

  • Subjects meeting any of the following criteria are not eligible to attend this clinical study:
  • 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;
  • 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:
  • Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout);
  • Infection/septic arthritis, or other acute inflammatory arthritis;

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Interventions

DRUGIBI3011

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

DRUGIBI3011 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

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NCT07295496


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