SCHIZOPHRENIA 1 (Disorder)Phase 3NCT07759869
A Study to Evaluate the Long-term Safety of HS-10380 in Patients With Schizophrenia
A Phase 3 study testing HS-10380 in people with SCHIZOPHRENIA 1 (Disorder), run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder)
- What is being tested?
- HS-10380
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2026to 31 Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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 .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191
Tianmei Si, 010-62723761, si.tian-mei@163.com
About this study
Official title: A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety of HS-10380 in Chinese Adult Patients With Schizophrenia
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.
Read the detailed description
The study will comprise 3 periods : a Screening Period, an Open-Label Treatment Period during which participants will be treated for 52 weeks and a 14-day Follow-up Period before an End of Study (EOS) Visit. The total study duration for each participant on this study is 57 weeks.
- Conditions
- SCHIZOPHRENIA 1 (Disorder)
- Being tested
- HS-10380
- Keywords
- Schizophrenia, Long-term, open-label, HS-10380
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10380Drug
Oral;QD;W1:dose titration; W1-2:dose adjust to optimal level;Week 3-52:stable dose.
| Study group | Role | What they receive |
|---|---|---|
| HS-10380 (1.5-6mg) | Experimental | Not described Receives: Drug: HS-10380 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The positive symptoms in schizophrenia are the excess or distortion of normal function and the negative symptoms are the diminution or loss of normal functions . PANSS total score is the sum of all 30 items with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms.
Measured: Open-label extension baseline, week 52
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score
The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
Measured: Open-label extension baseline, week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start9 Sep 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759869
- Sponsor's protocol ID
- HS-10380-303
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety of HS-10380 in Chinese Adult Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT07759869
- Acronym / sponsor ID
- HS-10380-303
- Conditions
- SCHIZOPHRENIA 1 (Disorder)
- Keywords
- Schizophrenia, Long-term, open-label, HS-10380
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will comprise 3 periods : a Screening Period, an Open-Label Treatment Period during which participants will be treated for 52 weeks and a 14-day Follow-up Period before an End of Study (EOS) Visit. The total study duration for each participant on this study is 57 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-10380 (1.5-6mg) | Experimental | Drug: HS-10380 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10380Oral;QD;W1:dose titration; W1-2:dose adjust to optimal level;Week 3-52:stable dose. | Drug | HS-10380 (1.5-6mg) |
Primary outcome
Incidence and severity of adverse events (AE)
Time frame: From first dose to end of study (Up to approximately 54 weeks )
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.
Incidence and severity of serious adverse events (SAE)
Time frame: From first dose to end of study (Up to approximately 52 weeks)
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.
Incidence of Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation
Time frame: From first dose to end of study (Up to approximately 54 weeks )
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.
2 secondary outcomes
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Open-label extension baseline, week 52
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score
Time frame: Open-label extension baseline, week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
Related trials for SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 3
Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
SCHIZOPHRENIA 1 (Disorder)
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
Not yet recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 2
SCHIZOPHRENIA 1 (Disorder), Schizo Affective Disorder
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
Not yet recruiting
Online Intervention To Improve Motivation
Schizophrenia Prodromal, SCHIZOPHRENIA 1 (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-10380 in people with SCHIZOPHRENIA 1 (Disorder), run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianmei Si (010-62723761, si.tian-mei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AE) (time frame: From first dose to end of study (Up to approximately 54 weeks )). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.