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

NCT07295496 | Recruiting Phase 1

• 1 other identifier: CIBI3011A101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Acute Gout Flare

Keywords

acute gout flare

Outcome Measures

Primary Outcomes (1)

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

  To investigate the safety characteristics.

  12 week

Secondary Outcomes (6)

• Immunogenic outcome

  12 week

• AUC

  12 Week

• Cmax

  12 Week

• CL or CL/F

  12 Week

• V or V/F

  12 Week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

IBI3011 placebo group

Drug: IBI3011 Placebo

IBI3011

ACTIVE COMPARATOR

IBI3011 group

Drug: IBI3011

Interventions

IBI3011 DRUG

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

IBI3011

IBI3011 Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Central Study Contacts

Chunmiao Li

CONTACT

0512-69566088; chunmiao.li@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 19, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): June 7, 2026
• Study Completion (Estimated): June 7, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CN (1)