IBI3011: * Anti-IL-RAP humanised monoclonal antibody injection
* 300 mg (2.0 mL)/vial
* Administered in accordance with the study protocol
* Single administration only
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
Study 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
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) — 12 week To investigate the safety characteristics.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Soochow University
Suzhou
Jiangsu
More Innovent Biologics (Suzhou) Co. Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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