Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT06501534
Eligibility Criteria:
Inclusion criteria:
1. Participants must be aged between 18 and 75 years old (inclusive, as of the time of signing the informed consent form), with no gender restrictions;
2. Body Mass Index (BMI) should fall within the range of 18.0 to 40.0 kg/m² (including both ends of the range);
3. Subjects must meet the 2015 ACR/EULAR classification criteria for the diagnosis of gout (refer to Appendix 4);
4. At the screening stage, subjects must have a blood uric acid level of ≥480 μmol/L;
5. Subjects must voluntarily sign the informed consent form and agree to strictly adhere to the requirements outlined in this protocol.
Exclusion criteria (brief):
1. History of allergy to any component of Tigulixostat;
2. Previous allergy or intolerance to Febuxostat;
3. Subjects who have taken uric acid lowering medications within 2 weeks prior to screening;
4. Subjects who experienced an acute gout flare-up within 4 weeks prior to screening or immediately before the first dose administration;
5. Subjects considered to have secondary gout (elevated serum uric acid due to causes other than renal insufficiency);
6. Subjects with a history of xanthinuria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06501534
Study Brief:
Protocol Section:
NCT06501534