Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

January 4, 2025

Primary Completion Date

May 4, 2025

Study Completion Date

June 30, 2025

Conditions
Healthy Adult Male and Female Volunteers
Interventions
DRUG

Y-4 tables

Each subject will receive a single dose and multiple doses. During the single dose phase (Day1-Day4), the subjects will be administered with single dose of Y-4 tablets on fasting state in the morning of Day D1. During the multiple dosing phase (Day5-Day13), the subjects will be required to administer with Y-4 tablets continuously for 6 days, BID of Day5-Day9 (once in the morning and once in the evening, Q12h) and QD of Day10, for a total of 11 doses.

DRUG

Y-4 placebos

Each subject will receive a single dose and multiple doses. During the single dose phase (Day1-Day4), the subjects will be administered with single dose of Y-4 placebos on fasting state in the morning of Day D1. During the multiple dosing phase (Day5-Day13), the subjects will be required to administer with Y-4 placebos continuously for 6 days, BID of Day5-Day9 (once in the morning and once in the evening, Q12h) and QD of Day10, for a total of 11 doses.

Trial Locations (1)

100000

RECRUITING

Beijing Tiantan Hospital, Capital Medical University Beijing, Beijing

Sponsors
All Listed Sponsors
collaborator

Neurodawn Pharmaceutical Co., Ltd.

INDUSTRY

lead

Beijing Tiantan Hospital

OTHER