Trials / Completed
CompletedNCT03698617
A Phase IIa Study Investigating the Tolerance, Efficacy and Safety of HSK3486
A Phase IIa, Open-label, Propofol-controlled ,Dose-escalation, Multi-center Study to Evaluate the Tolerance, Efficacy and Safety of HSK3486 for Induction of General Anesthesia in Elective Surgery Patients.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in elective surgery patients.This study is consisted of two cohorts, dose-escalation and dose-expansion cohorts. The doses in dose- expansion cohort were selected from dose-escalation results.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HSK3486 | For induction of general anesthesia In dose escalation cohort: Starting from 0.4mg/kg, up-titration dose by 0.1mg/kg until 0.8mg//kg or down-titration dose by 0.1mg/kg until 0.1mg/kg based on the efficacy and safety results. |
| DRUG | Propofol | For induction of general anesthesia |
Timeline
- Start date
- 2016-12-06
- Primary completion
- 2018-06-29
- Completion
- 2018-07-18
- First posted
- 2018-10-09
- Last updated
- 2018-10-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03698617. Inclusion in this directory is not an endorsement.