NCT05857449

An Exploratory Study of LPM3480392 at Different Infusion Rates in Chinese Healthy Subjects

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LPM3480392 Injection at Different Rates in Healthy Subjects in a Phase I Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study evaluated the safety, tolerability and PK/PD characteristics of LPM3480392 injection by intravenous infusion at different rates in healthy subjects.The experiment was divided into Part A and Part B. Part A is a open label ,three cycle , fixed sequence dosing study .Twelve healthy male subjects were planned to be enrolled, and the same dose (X1mg)of LPM3480392 injection was intravenously injected at different infusion times in different drug administration cycles. Part B is an open label ,two cycle , fixed sequence dosing study .Ten healthy male subjects (subjects not enrolled in Part A) were given LPM3480392 injection in 2 minutes , each subject was given X2mg at the first cycle and X3mg at the second cycle .

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LPM3480392	Intravenous infusion

Timeline

• Start date: 2021-11-08
• Primary completion: 2022-03-09
• Completion: 2022-03-09
• First posted: 2023-05-12
• Last updated: 2023-05-12

Locations

1 site across 1 country: China