Overview

Phase II Study to Evaluate Efficacy and Safety of D-0120 Administered in Combination With Allopurinol in Subjects With Gout

Status:
Not yet recruiting

Trial end date:
2024-04-30

Target enrollment:
0

Participant gender:
All

Summary

D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

InventisBio Co., Ltd

Criteria

Inclusion Criteria:

- Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate
urate-lowering response

- Subject has reported at least 2 gout flares in the previous 12 months.

- Body Mass Index (BMI) between 18.0 and 40.0 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