NCT06764147

Safety and Pharmacokinetics/ Pharmacodynamics of Methoxyethyl Etomidate Hydrochloride in Healthy Elderly Subjects

Phase 1 Pharmacokinetic Study of Methoxyethyl Etomidate Hydrochloride for Injection With a Single Dose in Elderly Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ahon Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

16 subjects were divided into two groups: One group consisted of healthy non-elderly subjects aged 18-64 years (including boundary value). The other group was healthy elderly subjects, aged ≥65 years old, of which no less than 3 cases were ≥75 years old, with 8 subjects in each group.Healthy non-elderly subjects will be included as matched control subjects. The gender of healthy non-elderly subjects was consistent with that of healthy elderly subjects. The mean body weight of the healthy non-elderly subjects was within the range of the mean body weight of the healthy elderly subjects ±10 kg. All patients received a single intravenous injection of 0.8mg/kg ET-26. To evaluate the pharmacokinetic characteristics of ET-26 and provide guidance for the clinical application of ET-26-hcl.

Conditions

• Healthy Elderly Subjects

Interventions

Type	Name	Description
DRUG	ET-26HCl	The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s.

Timeline

• Start date: 2023-12-25
• Primary completion: 2024-02-02
• Completion: 2024-02-02
• First posted: 2025-01-08
• Last updated: 2025-01-24

Locations

1 site across 1 country: China