drugset
drugset / Trial / NCT02749097

A PHASE I, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE DOSE ESCALATION STUDY TO INVESTIGATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SHR0534 IN HEALTHY VOLUNTEERS

NCT02749097 ↗

Phase 1 Completed 40 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, placebo-controlled, single dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with starting dose of 10 mg followed by dose escalation groups up to 200 mg. Eight subjects will be randomized in 3:1 ratio in each cohort to receive the study drug or placebo.

Timeline

Start
2013-10
Primary completion
2013-12
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject SHR0534 Unknown 10 mg Oral
Subject SHR0534 Unknown 25 mg Oral
Subject SHR0534 Unknown 50 mg Oral
Subject SHR0534 Unknown 100 mg Oral
Subject SHR0534 Unknown 200 mg Oral

Indications

No indication recorded.