New injection aimed at easing gout flares enters early human testing
NCT ID NCT07295496
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a single dose of a new antibody injection in 64 people. Part A includes healthy volunteers to check safety, and Part B includes people with an acute gout flare. The main goal is to see if the drug is safe and how the body processes it.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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64 people
The number who actually took part.
- Started
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Dec 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.