Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333977
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2023-07-31
Brief Title:
A Study of LC542019 in Healthy Subjects and Subjects With T2DM
Sponsor:
LG Chem
Organization:
LG Chem
Study Overview
Official Title:
A First in Human Randomized Double-Blind Placebo-Controlled Single and Multiple Ascending Dose Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of LC542019 in Healthy Subjects and Subjects With T2DM
Status:
COMPLETED
Status Verified Date:
2024-03
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:
to assess the safety tolerability Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes T2DM
Detailed Description:
The study will be conducted in 2 parts
Part 1 Single Ascending Dose This part will include 6 sequential dose cohorts S1-S6
Part 2 Multiple Ascending Dose This part will include 5 sequential dose cohorts M1-M5 Cohorts M1-M4 will enroll healthy subjects Cohort M5 will enroll subjects with T2DM
Part 1 Single Ascending Dose This part will include 6 sequential dose cohorts S1-S6
Part 2 Multiple Ascending Dose This part will include 5 sequential dose cohorts M1-M5 Cohorts M1-M4 will enroll healthy subjects Cohort M5 will enroll subjects with T2DM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None