Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04707131
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2021-01-11
Brief Title:
A Study of Single Ascending Dose of LEM-S401 in Healthy Participants
Sponsor:
Lemonex Inc
Organization:
Lemonex
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Single Ascending Dose Phase I Clinical Trial to Evaluate the Characteristics of the Safety Tolerability and Pharmacokinetics of LEM-S401 in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2023-02
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 primary objective of the study is to assess the safety and tolerability of single dose of LEM-S401 in healthy adult subjects
Detailed Description:
This study is designed to evaluate the safety and tolerability of LEM-S401 administered as subcutaneous injection in healthy adult subjects
Overall 18 subjects will be studied in 3 groups Each subject will receive LEM-S401 or placebo subcutaneously
Overall 18 subjects will be studied in 3 groups Each subject will receive LEM-S401 or placebo subcutaneously
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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