A Study to Evaluate the Long-term Safety of HS-10380 in Patients With Schizophrenia

NCT07759869 | Not Yet Recruiting Phase 3

• 1 other identifier: HS-10380-303
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this open-label phase 3 study is to evaluate the safety of HS-10380 on the incidence, severity, relationship to investigational product of adverse events (AE), serious adverse events (SAE), and adverse events leading to study drug discontinuationin Chinese adult participants with schizophrenia.

Conditions

SCHIZOPHRENIA 1 (Disorder)

Keywords

Schizophrenia, Long-term, open-label, HS-10380

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of adverse events (AE)

  TEAEs are defined as events with an onset date on or after the first dose of HS-10380. An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event.

  From first dose to end of study (Up to approximately 54 weeks )

• Incidence and severity of serious adverse events (SAE)

  An SAE is any untoward medical occurrence, in the view of either the investigator or sponsor, that results in death; is life-threatening; results in inpatient hospitalization or prolongation of existing hospitalization ; results in persistent or significant disability/incapacity, and/or; is a congenital anomaly/birth defect.

  From first dose to end of study (Up to approximately 52 weeks)

• Incidence of Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation

  TEAEs are defined as events with an onset date on or after the first dose of HS-10380. An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event.

  From first dose to end of study (Up to approximately 54 weeks )

Secondary Outcomes (2)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

  Open-label extension baseline, week 52

• Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score

  Open-label extension baseline, week 52

Study Arms (1)

HS-10380 (1.5-6mg)

EXPERIMENTAL

Drug: HS-10380

Interventions

HS-10380 DRUG

Oral;QD;W1:dose titration; W1-2:dose adjust to optimal level;Week 3-52:stable dose.

HS-10380 (1.5-6mg)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is aged 18-65 years, inclusive, at screening.
• Body mass index must be ≥18.0 and ≤40.0 kg/m² at screening.
• Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria.
• Willing and able to give informed consent/assent as per local requirements.
• Participants are willing and able to discontinue all antipsychotic medications prior to the baseline visit, as determined by the investigator.

You may not qualify if:

• Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
• Judged by the investigator as having treatment-resistant schizophrenia.
• Patients with risk of violent or destructive behavior, or suicidal risk.
• History or presence of clinically significant disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
• Any surgical condition or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a risk to trial participants, such as history of gastrointestinal surgery (gastrectomy, gastroenterostomy, bowel resection, etc.), urinary tract obstruction, or dysuria.
• History of severe allergic reactions.
• Female patients who are pregnant, in puerperium, or lactating at screening or baseline.
• History of drug abuse within 1 year prior to screening.
• History of alcohol abuse within 6 months prior to screening.
• Abnormal physical examination findings、vital signs or 12-lead electrocardiogram (ECG) at screening .

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Tianmei Si

CONTACT

010-62723761; si.tian-mei@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 9, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

CN (1)