drugset / Trial / NCT03291782

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

NCT03291782

Phase 1 Completed 39 enrolled InventisBio Co., Ltd
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2017-09-13
Primary completion
2018-04-06
Completion
2018-08-06

Drugs

EvaluationDrugModalityDoseRoute
Subject D-0120 Unknown Oral

Indications