D-0120 Safety and PK/PD Study in China
NCT03923868 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2022-05-06
Summary
It is a randomized, double-blind, placebo-controlled, multiple-administration, multiple-dose, dose-escalating, phase Ib/IIa clinical study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy subjects and hyperuricemia patients (gout or asymptomatic) in China.
Conditions
- Hyperuricemia or Gout
Interventions
- DRUG
-
D-0120
D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days
Sponsors & Collaborators
-
InventisBio Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-04-18
- Primary Completion
- 2021-12-31
- Completion
- 2021-12-31
- FDA Drug
- Yes
Countries
- China
Study Locations
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