NCT05663593 is a Phase 1 clinical trial of HSK31858, tablet in Healthy Volunteers, sponsored by Haisco Pharmaceutical Group Co., Ltd..

Who is sponsoring NCT05663593?

NCT05663593 is sponsored by Haisco Pharmaceutical Group Co., Ltd..

What drugs are being tested in NCT05663593?

Interventions in NCT05663593: HSK31858, tablet, Placebo, tablet.

What condition does NCT05663593 study?

NCT05663593 studies Healthy Volunteers.

Is NCT05663593 still recruiting?

NCT05663593 is currently completed. Last updated 23 December 2022.

Last reviewed 2022-12-23 · How we verify

NCT05663593

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

Safety, Tolerability,PK/PD, Food Effect of Single and Multiple Ascending Doses of HSK31858 in Healthy Volunteers

Completed Phase 1 Last updated 23 December 2022

What this trial tests

Phase 1 trial testing HSK31858, tablet in Healthy Volunteers in 74 participants. Completed in 30 November 2022.

Timeline

23 February 2022

Primary endpoint
15 August 2022

30 November 2022

Quick facts

Lead sponsor	Haisco Pharmaceutical Group Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	74
Start date	23 February 2022
Primary completion	15 August 2022
Estimated completion	30 November 2022
Sites	1 location across China

Drugs / interventions tested

HSK31858, tablet — full drug profile →
Placebo, tablet

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

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

Who can join

Adults 18 to 45, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase I, randomised, double-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HSK31858 in healthy volunteers

Publications & conference data

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

Dipeptidyl peptidase-1 inhibitors in bronchiectasis.
Johnson E, Gilmour A, Chalmers JD. · · 2025 · cited 5× · PMID 40533102 · DOI 10.1183/16000617.0257-2024
Safety, tolerability, pharmacokinetics and pharmacodynamics of HSK31858, a novel oral dipeptidyl peptidase-1 inhibitor, in healthy volunteers: An integrated phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study.
Wang Y, Yu C, Hu M, Wang L, et al · · 2025 · cited 3× · PMID 40170587 · DOI 10.1002/bcp.70027
Therapies for bronchiectasis: mechanisms and potential effects.
Yu L, Zhu HR, Jin XH, Ding J, et al · · 2026 · PMID 41789076 · DOI 10.3389/fimmu.2026.1735598

Verify or expand the search:

Other trials of HSK31858, tablet

Trials testing the same drug.

NCT06660992 — A Study to Assess the Efficacy and Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis · Phase 3 · recruiting
NCT05023525 — A Study of Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosed of HSK31858 in Healthy Volunteers · Phase 1 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Haisco Pharmaceutical Group Co., Ltd. trials

Trials by the same sponsor.

NCT07533786 — A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdomina · Phase 2 · not yet recruiting
NCT07519070 — A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44 · Phase 3 · not yet recruiting
NCT07503587 — Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07521345 — A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healt · Phase 1 · recruiting
NCT07335055 — A Study for HSK47388 in Participants With Ulcerative Colitis · Phase 2 · 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 NCT05663593 (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 Haisco Pharmaceutical Group Co., Ltd.
Last refreshed: 23 December 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/NCT05663593.

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