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

NCT05857449 ↗

Phase 1 Completed 23 enrolled Luye Pharma Group Ltd.
Non-randomizedSequentialDouble-blindTreatment

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 .

Timeline

Start
2021-11-08
Primary completion
2022-03-09
Completion
2022-03-09

Drugs

EvaluationDrugModalityDoseRoute
Subject LPM3480392 Unknown — Intravenous

Indications

No indication recorded.