Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862974
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2021-12-06
Brief Title:
A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects
Sponsor:
Luye Pharma Group Ltd
Organization:
Luye Pharma Group Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Dose-increasing Phase I Clinical Trial to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of a Single Intravenous Infusion of LPM3480392 Injection in Healthy Subject
Status:
COMPLETED
Status Verified Date:
2023-05
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:
This is a randomized double-blind placebo-controlled dose-increasing Phase I clinical trial to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of a single intravenous infusion of LPM3480392 injection in healthy subject
Detailed Description:
A total of 80 healthy subjects will be allocated to 1 of 8 cohorts cohort 18 in the study each cohort including 10 subjects 8 subjects will receive investigational new drug IND product and 2 receive placebo Each subject in fasted state will be randomly assigned to receive a single dose of LPM3480392 or placebo intravenously
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