NCT02603185

PhaseⅠFirst-in-Human Study of Hemay007 in Healthy Volunteers

A First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Hemay007

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Hemay Pharmaceutical PTY. LTD. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	Hemay007
DRUG	placebo

Timeline

• Start date: 2017-01-09
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2015-11-11
• Last updated: 2017-10-24

Locations

1 site across 1 country: Australia