Last reviewed · How we verify
NCT03751969
A Study Evaluating the Mass Balance of Micro-dose[14C]HSK3486 Emulsion Injection in Healthy Adults
Phase 1 trial testing HSK3486 in Anesthesia. Withdrawn.
1 November 2020
Quick facts
| Lead sponsor | Sichuan Haisco Pharmaceutical Group Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 30 March 2020 |
| Primary completion | 1 November 2020 |
| Estimated completion | 1 December 2020 |
Drugs / interventions tested
- HSK3486 — full drug profile →
Conditions studied
- Anesthesia — all drugs for Anesthesia →
- Sedation — all drugs for Sedation →
Sponsor
Sichuan Haisco Pharmaceutical Group Co., Ltd — full company profile →
Who can join
Adults 18 to 49, male only, with Anesthesia or Sedation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is designed to evaluate the mass balance in healthy Chinese male subjects after receiving a single dose of intravenous \[14C\]HSK3486, so as to assess the overall pharmacokinetics and safety of HSK3486 in humans and provide a reference for reasonable use of this drug.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03751969
- 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 recruiting trials for Anesthesia
Currently open trials in the same condition.
- NCT07294092 — Ketamine and Propofol NeuroImaging · EARLY_PHASE1 · recruiting
- NCT07290205 — Remimazolam NeuroImaging · EARLY_PHASE1 · recruiting
- NCT07465185 — Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery · Phase 2 · recruiting
- NCT07269808 — Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration · Phase 3 · recruiting
- NCT07443254 — Prospective IR-led Sedation Feasibility · Phase 1, PHASE2 · recruiting
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 NCT03751969 (US National Library of Medicine, public domain)
- 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: 2 June 2022
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/NCT03751969.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing