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

NCT05941247 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-03-01

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Hemay Pharmaceutical PTY. LTD.

    collaborator INDUSTRY

  • Ganzhou Hemay Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Christopher J Argent · Scientia Clinical Research Ltd

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-17
Primary Completion
2023-08-08
Completion
2023-08-20

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05941247 on ClinicalTrials.gov