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

Innovent Biologics

Status and phase: Enrolling; Phase 1

Conditions: Acute Gout Flare

Treatments: Drug: IBI3011 Placebo; Drug: IBI3011

Study type: Interventional

Funder types: Industry

Identifiers

NCT07295496

CIBI3011A101

Details and patient eligibility

About

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)

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

IBI3011 placebo group

Treatment:

Drug: IBI3011 Placebo

IBI3011

Active Comparator group

Description:

IBI3011 group

Treatment:

Drug: IBI3011