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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Gout Flare
• Intervention / Treatment: Drug: IBI3011 Placebo; Drug: IBI3011

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • the First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; IBI3011 placebo group	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
Active Comparator: IBI3011; IBI3011 group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	To investigate the safety characteristics.	12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenic outcome	The incidence of antidrug Antibody (ADA) and/or Neutralising antibodies (NAb)	12 week
AUC	Describing the Area Under Curve	12 Week
Cmax	Describing the Maximum Serum Concentration of Drug	12 Week
CL or CL/F	Describing the Clearance	12 Week
V or V/F	Describing the Apparent Volume of Distribution	12 Week
t1/2	Describing the Half Life	12 Week

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): June 7, 2026
• Study Completion (Estimated): June 7, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: acute gout flare
• Other Study ID Numbers: CIBI3011A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No