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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 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.
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