NCT04197661 is a Phase 1 clinical trial of HSK3486 in Healthy Elderly Subjects, sponsored by Sichuan Haisco Pharmaceutical Group Co., Ltd.

Who is sponsoring NCT04197661?

NCT04197661 is sponsored by Sichuan Haisco Pharmaceutical Group Co., Ltd.

What drugs are being tested in NCT04197661?

Interventions in NCT04197661: HSK3486, HSK3486, HSK3486, HSK3486.

What condition does NCT04197661 study?

NCT04197661 studies Healthy Elderly Subjects.

Is NCT04197661 still recruiting?

NCT04197661 is currently completed. Last updated 17 December 2020.

Last reviewed 2020-12-17 · How we verify

NCT04197661

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Healthy Elderly Subjects

Completed Phase 1 Last updated 17 December 2020

What this trial tests

Phase 1 trial testing HSK3486 in Healthy Elderly Subjects in 32 participants. Completed in 22 May 2020.

Timeline

25 December 2019

Primary endpoint
22 January 2020

22 May 2020

Quick facts

Lead sponsor	Sichuan Haisco Pharmaceutical Group Co., Ltd
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	32
Start date	25 December 2019
Primary completion	22 January 2020
Estimated completion	22 May 2020
Sites	1 location across China

Drugs / interventions tested

HSK3486 — full drug profile →
HSK3486 — full drug profile →
HSK3486 — full drug profile →
HSK3486 — full drug profile →

Conditions studied

Healthy Elderly Subjects — all drugs for Healthy Elderly Subjects →

Sponsor

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

Who can join

Adults 18 to 75, any sex, with Healthy Elderly Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is a single-center, open-label, dose-finding, Phase I clinical study evaluating the pharmacokinetics, pharmacodynamics, and safety characteristics of HSK3486 in healthy elderly subjects.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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

Verify or expand the search:

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04197661 (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: 17 December 2020

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/NCT04197661.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing