A Phase I Clinical Study of Hemay808

Safety Issues Clinical Trial

Official title: A Phase I Clinical Study Assessed the Safety Tolerance and Pharmacokinetic Characteristics of Hemay808 in Healthy Adult Volunteers

Status Completed

Clinical Trial Summary

This is a first-in-human study in health volunteers. The purpose is the local tolerability and systemic safety of Hemay808, which is an ointment made of a novel small molecule Hemay028. The safety and systemic pharmacokinetics (PK) of Hemay028 will be evaluated following topical application of Hemay808 to healthy volunteers.

Clinical Trial Description

There are two pre-test groups. Group1 use Hemay808 and placebo on sensitive areas. Group2 will only topical use Hemay808 on 5%BSA.

After 2 pre-test group, 4 formal testing groups will start. 1% Hemay808 apply to 25%BSA; 3% Hemay808 apply to 25%BSA; 3% Hemay808 apply to 55%BSA; 7% Hemay808 apply to 25%BSA. First a single doses then wash-out for three days, after that subjects will applicant twice daily for 7 days to assess the local skin tolerability, and systemic PK of these treatments.

Approximately 42 healthy adult volunteers will be enrolled in this study with 8- 10 volunteers each cohort. ;

Related Conditions & MeSH terms

• Safety Issues

• NCT number: NCT04100642
• Study type: Interventional
• Source: Tianjin Hemay Pharmaceutical Co.,Ltd
• Status: Completed
• Phase: Phase 1
• Start date: April 8, 2019
• Completion date: December 22, 2019