The 2nd Affiliated Hospital of WMU
Wenzhou, Zhejiang, 325027, China
NCT Number: NCT03698617
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Wenzhou, Zhejiang, 325027, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
For induction of general anesthesia
Time frame: during induction of general anesthesia on day 1
To find the MTD or the RP2D of HSK3486 in the induction of general anesthesia, the success rate of induction of general anesthesia is the primary outcome measurement.
Time frame: during induction of general anesthesia on day 1
Time frame: during induction of general anesthesia on day 1
Time frame: during induction of general anesthesia on day 1
Time frame: Pre-dose to 48 hours post-dose
Change from baseline in Mini-Mental State Examination (MMSE) total score
Time frame: pre-dose to 20 minutes post-dose
safety endpoits
Time frame: pre-dose to 20 minutes post-dose
safety endpoits
Time frame: pre-dose to 20 minutes post-dose
safety endpoits
Time frame: Pre-dose to 48 hours post-dose
safety endpoits
Sichuan Haisco Pharmaceutical Group Co., Ltd
Industry
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.