drugset / Trial / NCT02603185

PhaseⅠFirst-in-Human Study of Hemay007 in Healthy Volunteers

NCT02603185 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

This phase I study designed in 3 parts is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers. The safety, tolerability and pharmacokinetics of ascending single and multiple dose of Hemay007 will be assessed in Part 1 and Part 3, respectively. Food effect following a single oral dose will be evaluated in Part 2.

Timeline

Start
2017-01-09
Primary completion
2018-03
Completion
2018-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Hemay007 Unknown 0.2 g Oral
Subject Hemay007 Unknown 0.6 g Oral
Subject Hemay007 Unknown 1.2 g Oral
Subject Hemay007 Unknown 2 g Oral
Subject Hemay007 Unknown 3 g Oral