drugset / Trial / NCT02423538

First-in-Human Single Ascending Dose of SHR0302

NCT02423538

Phase 1 Unknown 64 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral doses of SHR0302 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of SHR0302 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Timeline

Start
2015-04
Primary completion
2016-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject SHR0302 Unknown 1 mg Oral
Subject SHR0302 Unknown 5 mg Oral
Subject SHR0302 Unknown 10 mg Oral

Indications