NCT04037657

Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Female Subjects.

A Phase 1b, Positive-controlled, Dose-escalation Study to Determine the Safety, Pharmacodynamics and Pharmacokinetics of a Single Intravenous Dose of HSK3486 in Healthy Female Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

This study was a single-center positive-controlled, randomized, dose-escalation study of HSK3486 in healthy female subjects administered as a single IV bolus dose.Subjects were confined to the study unit from the evening of Day -1 until the morning of Day 2, then were required to return for a follow up visit on Day 5. Intensive safety, PD and PK assessments were performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).

Conditions

• Anesthesia
• Sedation

Interventions

Type	Name	Description
DRUG	HSK3486	HSK3486 was administered as a single dose over a 1 minute infusion period. There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol).
DRUG	Propofol	Propofol, at a dose of 2.5 mg/kg, was administered as a 1 minute infusion at a constant rate via infusion pump.

Timeline

• Start date: 2015-04-22
• Primary completion: 2015-06-09
• Completion: 2015-11-13
• First posted: 2019-07-30
• Last updated: 2019-07-31