NCT04197661

Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Healthy Elderly Subjects

A Study Evaluating Pharmacokinetics, Pharmacodynamics and Safety of Intravenous Administration of HSK3486 Injectable Emulsion in Healthy Elderly Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

It is a single-center, open-label, dose-finding, Phase I clinical study evaluating the pharmacokinetics, pharmacodynamics, and safety characteristics of HSK3486 in healthy elderly subjects.

Conditions

• Healthy Elderly Subjects

Interventions

Type	Name	Description
DRUG	HSK3486	Intravenously infuse 0.2 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
DRUG	HSK3486	Intravenously infuse 0.3 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
DRUG	HSK3486	Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
DRUG	HSK3486	Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.

Timeline

• Start date: 2019-12-25
• Primary completion: 2020-01-22
• Completion: 2020-05-22
• First posted: 2019-12-13
• Last updated: 2020-12-17

Locations

1 site across 1 country: China