NCT03923868

D-0120 Safety and PK/PD Study in China

A Randomized, Double-blind, Placebo-controlled, Multiple-administration, Multiple-dose, Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of D-0120 Tablets in Healthy Subjects and Hyperuricemia Patients in China

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: InventisBio Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	D-0120	D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days

Timeline

• Start date: 2019-04-18
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-04-23
• Last updated: 2022-05-06

Locations

6 sites across 1 country: China

Regulatory

• FDA-regulated drug study