drugset / Trial / NCT06747520

Phase 1 Renal Insufficiency Trial of Methoxyethyl Etomidate Hydrochloride

NCT06747520 ↗

Phase 1 Completed 24 enrolled Ahon Pharmaceutical Co., Ltd.
Non-randomizedParallel-groupOpen-labelOther

Summary

Twenty-four subjects were divided into three groups: subjects with mild renal insufficiency, subjects with moderate renal insufficiency and subjects with normal renal function, with 8 subjects in each group.Subjects with mild renal insufficiency and moderate renal insufficiency were enrolled first, and then subjects with normal renal function were matched according to age, weight and gender. All patients received a single intravenous injection of 0.8mg/kg ET-26. To compare the pharmacokinetic characteristics of ET-26 and etomidate acid in subjects with mild and moderate renal insufficiency and normal renal function, and to provide clinical guidance for the use of ET-26 in patients with mild and moderate renal insufficiency.

Timeline

Start
2023-11-30
Primary completion
2024-02-21
Completion
2024-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject ET-26HCl Unknown 0.8 mg/kg Intravenous