Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556966
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase Ⅰ Randomized Double-blind Placebo-controlled Single Dose Ascending Study to Assess the Safety Tolerability and Pharmacokinetics of LPM787000048 Maleate Sustained-release Tablet LY03020 in Chinese Healthy Adult Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center randomized double-blind placebo-controlled ascending single oral dose study to assess the safety tolerability and pharmacokinetics of LY03020 in Chinese healthy adult subjects
Detailed Description:
The study will set 25mg 5mg 10mg 20mg 40mg 60mg 80mg and 100mg a total of 8 dose groups Qualified subjects were enrolled in site at D-1 1 day before administration and randomizedThe subjects should fast for at least 10 hours before medication administration with no restrictions on water intake The subjects will be required to orally take LY03020 or a placebo on an empty stomach upon waking on D1 the day of medication administration From D1 to D7 they will undergo safety assessments and PK biological sample collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None