NCT05862974

A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 1\~8) 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LPM3480392	Intravenous infusion of 30min duration
DRUG	Placebo	Intravenous infusion of 30min duration

Timeline

• Start date: 2021-02-25
• Primary completion: 2021-11-02
• Completion: 2021-11-02
• First posted: 2023-05-17
• Last updated: 2023-05-17

Locations

1 site across 1 country: China