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NCT03698617

A Phase IIa Study Investigating the Tolerance, Efficacy and Safety of HSK3486

Completed Phase 2 Last updated 9 October 2018
What this trial tests

Phase 2 trial testing HSK3486 in Induction of General Anaesthesia in 114 participants. Completed in 18 July 2018.

Timeline
6 December 2016
Primary endpoint
29 June 2018
18 July 2018

Quick facts

Lead sponsorSichuan Haisco Pharmaceutical Group Co., Ltd
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment114
Start date6 December 2016
Primary completion29 June 2018
Estimated completion18 July 2018
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd — full company profile →

Who can join

Adults 18 to 65, any sex, with Induction of General Anaesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Safety and efficacy of ciprofol vs. propofol for sedation in intensive care unit patients with mechanical ventilation: a multi-center, open label, randomized, phase 2 trial.
    Liu Y, Yu X, Zhu D, Zeng J, et al · · 2022 · cited 58× · PMID 34924506 · DOI 10.1097/cm9.0000000000001912
  2. Safety, Pharmacokinetics, and Pharmacodynamics of a Single Bolus of the γ-aminobutyric Acid (GABA) Receptor Potentiator HSK3486 in Healthy Chinese Elderly and Non-elderly.
    Li X, Yang D, Li Q, Wang H, et al · · 2021 · cited 55× · PMID 34512361 · DOI 10.3389/fphar.2021.735700
  3. Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial.
    Zhu Q, Luo Z, Wang X, Wang D, et al · · 2023 · cited 32× · PMID 36680620 · DOI 10.1007/s11096-022-01529-x
  4. Protective effects of combined treatment with ciprofol and mild therapeutic hypothermia during cerebral ischemia-reperfusion injury.
    Wang YC, Wu MJ, Zhou SL, Li ZH. · · 2023 · cited 7× · PMID 36793629 · DOI 10.12998/wjcc.v11.i3.487
  5. Effects of Cipepofol on Cardiac Depolarization and Repolarization in Healthy Subjects: A Single-Center, Randomized, Placebo and Positive-Controlled Thorough QT Study.
    Kleiman R, Rudo T, Daley W, Hu M, et al · · 2026 · PMID 41858914 · DOI 10.2147/dddt.s565051

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