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

NCT ID: NCT07295496

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2026-06-07

Brief Summary

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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)

Detailed Description

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Conditions

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Acute Gout Flare

Keywords

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acute gout flare

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

IBI3011 placebo group

Group Type PLACEBO_COMPARATOR

IBI3011 Placebo

Intervention Type 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

IBI3011

IBI3011 group

Group Type ACTIVE_COMPARATOR

IBI3011

Intervention Type DRUG

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

Interventions

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IBI3011

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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;

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunmiao Li

Role: CONTACT

Phone: 0512-69566088

Email: [email protected]

Facility Contacts

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Liyan Miao, M.D.

Role: primary

Jian Wu, M.D.

Role: backup

Other Identifiers

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CIBI3011A101

Identifier Type: -

Identifier Source: org_study_id