NCT04100642

A Phase I Clinical Study of Hemay808

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Safety Issues

Interventions

Type	Name	Description
DRUG	Hemay808	topical apply
DRUG	Placebo	topical apply

Timeline

• Start date: 2019-04-08
• Primary completion: 2019-10-23
• Completion: 2019-12-22
• First posted: 2019-09-24
• Last updated: 2020-04-27

Locations

1 site across 1 country: China