drugset / Trial / NCT03006159

A Phase 1, Randomized, Placebo-controlled, Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Chinese Type 2 Diabetic Patients

NCT03006159 ↗

Phase 1 Completed 36 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, placebo-controlled, multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with dose of 5 mg, 10mg and 25 mg. Chinese Type 2 Diabetic patients will be randomized in each cohort to receive the study drug or placebo.

Timeline

Start
2015-03
Primary completion
2015-12
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject SHR0534 Unknown 5 mg Oral
Subject SHR0534 Unknown 10 mg Oral
Subject SHR0534 Unknown 25 mg Oral