Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06040372
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2023-08-21
Brief Title:
A First in Human Study to Assess the Safety Tolerability of LB54640 in in Healthy Overweight and Obese Subjects
Sponsor:
LG Chem
Organization:
LG Chem
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Single and Multiple Ascending Dose Study to Assess the Safety and Tolerability Pharmacokinetics and Pharmacodynamics of Compound LB54640 in Healthy Overweight and Obese Subjects
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this 4-weeks randomized double-blind placebo-controlled single and multiple ascending dose study is to assess the Safety and Tolerability of LB54640 in Healthy overweight and obese subjects
Detailed Description:
The study was conducted in 2 parts
Part 1 Single Ascending Dose This study part included 6 sequential dose cohorts S1-S6 enrolling 8 healthy subjects per cohort Cohort S3 was evaluate the effect of food
Part 2 Multiple Ascending Dose This part included 7 sequential dose cohorts M1-M7 enrolling 8 subjects per cohort Cohorts was evaluate safety Pharmacokinetics and Pharmacodynamics parameters in healthy overweight and obese subjects They were dosed once daily for 28 days with LB54640 or placebo
Part 1 Single Ascending Dose This study part included 6 sequential dose cohorts S1-S6 enrolling 8 healthy subjects per cohort Cohort S3 was evaluate the effect of food
Part 2 Multiple Ascending Dose This part included 7 sequential dose cohorts M1-M7 enrolling 8 subjects per cohort Cohorts was evaluate safety Pharmacokinetics and Pharmacodynamics parameters in healthy overweight and obese subjects They were dosed once daily for 28 days with LB54640 or placebo
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