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NCT03698617
A Phase IIa Study Investigating the Tolerance, Efficacy and Safety of HSK3486
Phase 2 trial testing HSK3486 in Induction of General Anaesthesia in 114 participants. Completed in 18 July 2018.
29 June 2018
Quick facts
| Lead sponsor | Sichuan Haisco Pharmaceutical Group Co., Ltd |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 114 |
| Start date | 6 December 2016 |
| Primary completion | 29 June 2018 |
| Estimated completion | 18 July 2018 |
| Sites | 1 location across China |
Drugs / interventions tested
Conditions studied
- Induction of General Anaesthesia — all drugs for Induction of General Anaesthesia →
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):
-
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT03698617
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HSK3486
Trials testing the same drug.
- NCT06795204 — Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT) · Phase 1 · completed
- NCT05486416 — Safety and Efficacy of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults With Elective Surgery · Phase 3 · completed
- NCT05614544 — Dose-Finding and Human Abuse Potential Study Of HSK3486 Injection In Nondependent, Recreational Central Nervous System D · Phase 1 · completed
- NCT07404306 — Part 1: Dose-Finding of HSK3486 Injection In Nondependent, Recreational Central Nervous System Depressant Users · Phase 1 · completed
- NCT05478174 — Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia · Phase 3 · completed
Other Sichuan Haisco Pharmaceutical Group Co., Ltd trials
Trials by the same sponsor.
- NCT04540016 — Mass Balance and Biotransformation of [14C]HSK7653 in Human · Phase 1 · completed
- NCT04564872 — HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus · Phase 3 · completed
- NCT04556851 — HSK7653 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise · Phase 3 · completed
- NCT04110886 — Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers · Phase 1 · completed
- NCT04595916 — Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03698617 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sichuan Haisco Pharmaceutical Group Co., Ltd
- Last refreshed: 9 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03698617.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing