Who is sponsoring NCT05196971?

NCT05196971 is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd..

What drugs are being tested in NCT05196971?

Interventions in NCT05196971: HS-10345 84mg, Placebo.

What condition does NCT05196971 study?

NCT05196971 studies Treatment Resistant Depressive Disorder.

Is NCT05196971 still recruiting?

NCT05196971 is currently completed. Last updated 9 March 2023.

Last reviewed 2023-03-09 · How we verify

NCT05196971

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

A Study To Evaluate The Safety, Tolerability And Pharmacokinetics of HS-10345 In Treatment-Resistant Depression

Completed Phase 1 Last updated 9 March 2023

What this trial tests

Phase 1 trial testing HS-10345 84mg in Treatment Resistant Depressive Disorder in 12 participants. Completed in 31 October 2022.

Timeline

28 October 2021

Primary endpoint
30 April 2022

31 October 2022

Quick facts

Lead sponsor	Jiangsu Hansoh Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	12
Start date	28 October 2021
Primary completion	30 April 2022
Estimated completion	31 October 2022
Sites	1 location across China

Drugs / interventions tested

HS-10345 84mg — full drug profile →
Placebo

Conditions studied

Treatment Resistant Depressive Disorder — all drugs for Treatment Resistant Depressive Disorder →

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 64, any sex, with Treatment Resistant Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of intranasal HS-10345 (84mg) compared with placebo in participants with treatment-resistant depression (TRD).

Publications & conference data

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

The Nasal-Brain Drug Delivery Route: Mechanisms and Applications to Central Nervous System Diseases.
Qiu Y, Huang S, Peng L, Yang L, et al · · 2025 · cited 18× · PMID 40487748 · DOI 10.1002/mco2.70213

Verify or expand the search:

Other Jiangsu Hansoh Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07468851 — A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radic · Phase 1, PHASE2 · not yet recruiting
NCT07483437 — A Study of HS-20136-2 in Healthy Participants · Phase 1 · not yet recruiting
NCT07535970 — A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Part · Phase 1 · not yet recruiting
NCT07503015 — Phase 1 Study of HS-20152 in Healthy Participants · Phase 1 · not yet recruiting
NCT07414953 — A Phase Ib Study of HS-10504 Combined Therapy in NSCLC · Phase 1 · not yet recruiting

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 NCT05196971 (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 Jiangsu Hansoh Pharmaceutical Co., Ltd.
Last refreshed: 9 March 2023

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/NCT05196971.

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