Hyperuricemia
Conditions
Brief summary
This is a randomized, open-label, parallel-controlled, multicenter clinical trial in primary hyperuricemia patients with or without gout.
Interventions
DRUGD-0120
Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group. Part B: Subjects will be assigned to D-0120 group 3.
DRUGBenzbromarone
Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group.
Sponsors
InventisBio Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol; 2. Subject who meets one of the following criteria: i. History of gout attack: Meeting 2015 ACR/EULAR Gout Classification Criteria and fasting serum uric acid ≥ 480 μmol/L at screening (local laboratory of study site) ii. For asymptomatic hyperuricemia, it is acceptable to meet either of the two criteria: 1. Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medical record or test report), diagnosis with hyperuricemia before screening, and fasting serum uric acid at screening ≥ 540 μmol/L (local laboratory of study site); 2. Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medical record or test report), diagnosis with hyperuricemia before screening, and fasting serum uric acid at screening ≥ 480 μmol/L (local laboratory of study site), with concomitant primary hypertension or primary hyperlipidemia or type 2 diabetes mellitus, which is treated with a stable dose of antihypertensive or lipid-lowering or hypoglycemic treatment for at least 3 months; 3. At screening, 18.0 kg/m2 ≤ body mass index (BMI) ≤ 32.0 kg/m2; 4. Hematology, Blood chemistry and Urinalysis examination were basically normal.
Exclusion criteria
1. Prior intolerance to benzbromarone or contraindication to medication; 2. Secondary hyperuricemia caused by tumor, chronic kidney disease, blood disease or drugs, etc.; 3. Arthropathy caused by arthritis rheumatoid, purulent arthritis, traumatic arthritis, psoriatic arthritis, pseudogout or systemic lupus erythematosus, etc.; 4. Arthropathy caused by chemotherapy, radiotherapy or chronic lead poisoning; 5. Urinary calculi confirmed by B-ultrasound during screening period;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with serum uric acid ≤ 360 μmol/L | Day 1 - Day 85 | Percentage of subjects with serum uric acid ≤ 360 μmol/L at week 12 of treatment - based on test results by the central lab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with serum uric acid≤ 360 μmol/L | Day 1 -Day 56 | Percentage of subjects with serum uric acid ≤ 360 μmol/L at weeks 4 and 8 of treatment - based on test results by the central lab; |
| Changes in serum uric acid | Day 1 - Day 85 | Changes in serum uric acid from baseline at weeks 4, 8 and 12 of treatment - based on test results by the central lab; |
| Change percentage in serum uric acid | Day 1 - Day 85 | Change percentage in serum uric acid from baseline at weeks 4, 8 and 12 of treatment - based on test results by the central lab. |
Countries
China
Outcome results
None listed