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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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)

Who May Be Eligible (Plain English)

Who May Qualify: Subjects are eligible for the study if they meet all of the following Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

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

Locations (1)

The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China