Gout
Conditions
Brief summary
D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.
Interventions
DRUGD-0120
increasing dose of D-0120
DRUGAllopurinol
standard dosing
Sponsors
InventisBio Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized , Open Label, Multiple Dose
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response * Subject has had at least 2 gout flares in the previous 12 months. * Body Mass Index (BMI) between 18.0 and 45.0 kg/m2 (inclusive). * Male and Female Subjects must agree to abstain or use effective contraception methods from the time of signing ICF and for the duration of study participation through 30 days after the last dose of study drug. * Subjects must have adequate clinical laboratory and ECG results as assessed by the Principal Investigator
Exclusion criteria
* Subjects with significant comorbidities, inadequate lab function, current (and within the past 5 years) diagnosis of cancer or any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study. * Women who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To assess the efficacy of D-0120 in combination with allopurinol to reduce serum urate levels in treatment of patients with gout by week 12 | 12 weeks |
Countries
United States
Contacts
STUDY_DIRECTORKathryn Stazzone
InventisBio Co., Ltd
Outcome results
None listed