NCT05941247

A Study to Evaluate the Effects of Single and Multiple Doses of Hemay005 Tablets in Health Caucasian Adult Volunteers

A Phase I, Single-arm, Open-label, Ethnobridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Oral Doses of Hemay005 Tablets in Healthy Caucasian Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the safety and tolerability of single and multiple oral doses of Hemay005 tablets in healthy Caucasian adult volunteers.

Detailed description

This is a phase I, single-arm, open-label ethno-bridging study. The study is being conducted to test a potential new treatment for Behçet's disease (BD) called Hemay005. The primary objective of this study is to evaluate the safety and tolerability of Hemay005 tablets after single and multiple oral doses in healthy Caucasian adult volunteers. The secondary objective of this study is to assess the pharmacokinetic parameters (time to remove the study drug from blood) of Hemay005 tablets after single and multiple oral doses. The results of Chinese healthy volunteers will be used as a historical control to compare the ethnic differences between Chinese and Caucasians. Approximately 12 eligible healthy (Caucasian) adult participants (male: female = 1:1) will be enrolled in this study. The participant will be screened to determine their suitability to take part in the study within 28 days before receiving a dose of the study treatment. There will be one confinement period in the clinic, which will start on the day before dosing with dosing on Day 1 and discharge on Day 11. The participant will be asked to attend the clinic for a final study visit on Day 20. This visit will be the end of the participation in this study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Hemay005 60 mg	The eligible healthy adult participants will enter Single-dose Administration Period, receiving a single administration of Hemay005 tablets orally at a dose of 60 mg on Day 1 morning under fasted condition. On Day 3, those participants will receive Hemay005 tablets at dose of 60 mg for 7 consecutive days, which will be administrated twice daily (BID) during Day 3 to Day 8 and only in the morning on Day 9.

Timeline

• Start date: 2023-07-17
• Primary completion: 2023-08-08
• Completion: 2023-08-20
• First posted: 2023-07-12
• Last updated: 2024-03-01

Locations

1 site across 1 country: Australia