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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days
Site 04
Bengbu, Anhui, China
Site 03
Nanjing, Jiangsu, China
Site 07
Nanjing, Jiangsu, China
Site 01- The second affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, China
The number of subjects with treatment-related adverse events as assessed
Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of subjects with treatment-related adverse events assessed
Time frame: Day 1 - Day 28
Time to observed Cmax (Tmax) for D-0120
Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Tmax
Time frame: Day 1 - Day 28
Area under the plasma concentration-time curve (AUC) for D-0120
Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive AUC
Time frame: Day 1 - Day 28
Maximum Observed Plasma Concentration (Cmax) of D-0120
Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Cmax
Time frame: Day 1 - Day 28
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Site 06
Huzhou, Zhejiang, China
Site 05
Wenzhou, Zhejiang, China