NCT03291782

D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, and Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics; Including an Open-label Cohort to Determine the Effect of Food on the Pharmacokinetics of D-0120-NA Tablet in Healthy Volunteers in the United States

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: InventisBio Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs). In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label manner; once in the fasted state and once in the fed state.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	D-0120	oral, single dose

Timeline

• Start date: 2017-09-13
• Primary completion: 2018-04-06
• Completion: 2018-08-06
• First posted: 2017-09-25
• Last updated: 2018-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study