A Phase 1, placebo and positive-controlled, dose-escalation study to determine the safety, pharmacodynamics and pharmacokinetics of a single intravenous injection ofHSK3486 in healthy subjects
Phase of Trial: Phase I
Latest Information Update: 22 Jun 2016
At a glance
- Drugs HSK 3486 (Primary)
- Indications Anaesthesia
- Focus Adverse reactions; Pharmacodynamics
- Acronyms HSK3486 SAD
- Sponsors Sichuan Haisike Pharmaceutical
- 15 Dec 2014 Addition of a cohort in the dosing schedule and reduction of dose of two other cohorts from 0.648 mg/kg and 0.972 mg/kg to 0.540 mg/kg and 0.648 mg kg respectively.
- 15 Dec 2014 Planned number of patients changed from 42 to 48, as reported by Australian New Zealand Clinical Trials Registry record.
- 15 Dec 2014 Status changed from recruiting to completed, as reported by Australian New Zealand Clinical Trials Registry record.