NCT06822153

Clinical Trial of the Effect of Methoxyethyl Etomidate Hydrochloride on the QT Interval of the Heart

A Single-center, Randomized, Open-label, Placebo-controlled Phase I Clinical Trial Was Conducted to Evaluate the Pharmacokinetics and QT Interval Effects of a Single Intravenous Injection of Methoxyethyl Etomidate Hydrochloride in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Ahon Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A single intravenous injection of 0.8mg/kg or 2.8mg/kg Et-26-hcl was given to 18 subjects. The effect of plasma concentration on QT interval was evaluated by C-QTc effect model, and the pharmacokinetic characteristics and safety of ET-26 and etomidate acid were evaluated.

Conditions

• QT Interval, Variation in

Interventions

Type	Name	Description
DRUG	ET-26 0.8mg/kg(low-dose) group	In a 2:1 ratio, Placebo was administered with normal saline and ET-26 0.8mg/kg for a duration of 60 ±5 seconds.
DRUG	ET-26 2.8mg/kg(high dose) group	In a 2:1 ratio, Placebo was administered with normal saline and ET-26 2.8mg/kg for a duration of 60 ±5 seconds.

Timeline

• Start date: 2023-11-09
• Primary completion: 2023-11-21
• Completion: 2023-11-21
• First posted: 2025-02-12
• Last updated: 2025-02-14

Locations

1 site across 1 country: China