SCHIZOPHRENIA 1 (Disorder)Phase 2NCT07550387

A Study Assessing the Efficacy and Safety of HS-10380 in Hospitalized Adults With Acute Schizophrenia

A Phase 2 study testing HS-10380 Low Dose, HS-10380 Medium dose and HS-10380 High Dose in people with SCHIZOPHRENIA 1 (Disorder), run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: SCHIZOPHRENIA 1 (Disorder)
What is being tested?: HS-10380 Low Dose, HS-10380 Medium dose and HS-10380 High Dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 363 participants
Where: 1 siteChina
Study dates: 23 May 2024to 19 Jan 2026
Phase: Phase 2
Are there results?: None posted in the registry

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.
Participant is experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months before screening.
Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening or baseline Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening: Item 1 (P1; delusions)\Item 2 (P2; conceptual disorganization)\Item 3 (P3; hallucinatory behavior)\Item 6 (P6; suspiciousness/persecution).

Who cannot join

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 neuropsychiatric, cardiovascular, urinary, digestive, respiratory, musculoskeletal, metabolic/endocrine, hematological, immune, dermatological, and oncological systems 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.
Received electroconvulsive therapy within 3 months prior to screening, or received systemic transcranial magnetic stimulation (TMS) therapy within 1 month prior to screening.
Used clozapine or long-acting antipsychotic medications within 6 months prior to screening, or within 5 half-lives of long-acting antipsychotic medications at screening, whichever is longer.
Previous inadequate response to adequate dose and duration of aripiprazole treatment (≥20 mg/day for at least 6 weeks).

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History of epilepsy (except febrile convulsions) or neuroleptic malignant syndrome.
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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Active-Controlled and Placebo-Controlled Phase 2b Clinical Study to Evaluate the Efficacy and Safety of HS-10380 in Chinese Adult Patients With Acute Schizophrenia

This is a Phase 2b, randomized, double-blind, parallel-group, active-controlled and placebo-controlled, multicenter inpatient study to examine the efficacy and safety of HS-10380 in adult Participants who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of HS-10380 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate the response rate, improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics.

Read the detailed description

This trial is a Phase 2b, randomized, double-blind, parallel-group, active-controlled and placebo-controlled, multicenter inpatient study, aims to further evaluate the efficacy and safety of HS-10380 in participants with acute schizophrenia, who were randomized (2:2:2:1:2) to receive HS-10380 ( Low Dose), HS-10380 (Medium dose), HS-10380 ( High Dose), Aripiprazole, or placebo, with the primary endpoint as the changes from baseline in PANSS total score on D42.

Conditions: SCHIZOPHRENIA 1 (Disorder)
Being tested: HS-10380 Low Dose, HS-10380 Medium dose, HS-10380 High Dose, Aripiprazole, Placebo
Keywords: Schizophrenia, PANSS, 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-10380 Low DoseDrug
W1：dose titration; W 2-3 dose adjust to optimal level；Week 4-6：stable dose
HS-10380 Medium doseDrug
W1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose
HS-10380 High DoseDrug
W1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose
AripiprazoleDrug
W1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose
PlaceboDrug
W1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose

Study groups in NCT07550387
Study group	Role	What they receive
HS-10380 Low Dose	Experimental	Not described Receives: Drug: HS-10380 Low Dose
HS-10380 Medium dose	Experimental	Not described Receives: Drug: HS-10380 Medium dose
HS-10380 High Dose	Experimental	Not described Receives: Drug: HS-10380 High Dose
Aripiprazole	Active comparator	Not described Receives: Drug: Aripiprazole
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42)
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Measured: Baseline and Week 6

Secondary outcomes (5)

Percentage of Positive and Negative Syndrome Scale (PANSS) Responders (>=40% Change in PANSS Total Score) at Day 42
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. 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 total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A PANSS responder is defined as a participant with at least a 40% change in PANSS total score compared to baseline at D42.
Measured: Baseline and Week 6
Change in Marder 5-factor score of the PANSS scale at Day 42 compared with baseline
The Marder 5-factor model is a validated subscale classification of the Positive and Negative Syndrome Scale (PANSS), which was proposed by psychiatrist Stephen R. Marder to refine the dimensional assessment of symptom severity in schizophrenia. It divides the 30 items of the PANSS into five distinct symptom domains, namely: Positive symptoms；Negative symptoms；Disorganization symptoms；Excitement/hostility symptoms；Anxiety/depression symptoms.
Measured: Baseline and Week 6
Change in Calgary Depression Scale for Schizophrenia (CDSS) score at Day 42 compared with baseline
The Calgary Depression Scale for Schizophrenia (CDSS) is a disease-specific, validated rating scale designed exclusively to assess depressive symptoms in patients with schizophrenia. Unlike general depression scales, it avoids overlap with schizophrenia core symptoms (e.g., anhedonia, avolition) that may mimic depressive manifestations, thus ensuring the accuracy of depression symptom evaluation in this population. The scale consists of 9 items, each rated on a 4-point Likert scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). The items cover key depressive domains including depressed mood, hopelessness, suicidal ideation, guilt feelings, insomnia, reduced appetite, early morning awakening, psychomotor retardation, and inability to feel pleasure.
Measured: Baseline and Week 6
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 42
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: Baseline and Week 6
Clinical Global Impression-Improvement (CGI-I) Score at Day 42
The Clinical Global Impression-Improvement (CGI-I) is a 7-point scale used to assess the patient's improvement relative to baseline status. The scale ranges from 1 to 7, with lower scores indicating greater improvement:1 = Very much improved;2 = Much improved;3 = Minimally improved;4 = No change;5 = Minimally worse;6 = Much worse;7 = Very much worse.
Measured: Week 1 and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 202419 Jan 2026

First posted24 Apr 2026
Study start23 May 2024
Primary completion2 Jan 2026
Study completion19 Jan 2026

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 363 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07550387
Sponsor's protocol ID: HS-10380-202
Status last verified: Apr 2026
First submitted: 9 Apr 2026
Last updated: 24 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
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

All SCHIZOPHRENIA 1 (Disorder) trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Active-Controlled and Placebo-Controlled Phase 2b Clinical Study to Evaluate the Efficacy and Safety of HS-10380 in Chinese Adult Patients With Acute Schizophrenia
ClinicalTrials.gov ID: NCT07550387
Acronym / sponsor ID: HS-10380-202
Conditions: SCHIZOPHRENIA 1 (Disorder)
Keywords: Schizophrenia, PANSS, HS-10380
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 363 participants (actual)
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 23 May 2024 (actual)
Primary completion: 2 Jan 2026 (actual)
Study completion: 19 Jan 2026 (actual)
First posted: 24 Apr 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
HS-10380 Low Dose	Experimental	Drug: HS-10380 Low Dose
HS-10380 Medium dose	Experimental	Drug: HS-10380 Medium dose
HS-10380 High Dose	Experimental	Drug: HS-10380 High Dose
Aripiprazole	Active comparator	Drug: Aripiprazole
Placebo	Placebo comparator	Drug: Placebo

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.
Participant is experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months before screening.
Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening or baseline Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening: Item 1 (P1; delusions)\Item 2 (P2; conceptual disorganization)\Item 3 (P3; hallucinatory behavior)\Item 6 (P6; suspiciousness/persecution).

Key exclusion criteria (12 listed)

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 neuropsychiatric, cardiovascular, urinary, digestive, respiratory, musculoskeletal, metabolic/endocrine, hematological, immune, dermatological, and oncological systems 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.
Received electroconvulsive therapy within 3 months prior to screening, or received systemic transcranial magnetic stimulation (TMS) therapy within 1 month prior to screening.
Used clozapine or long-acting antipsychotic medications within 6 months prior to screening, or within 5 half-lives of long-acting antipsychotic medications at screening, whichever is longer.

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-10380 Low DoseW1：dose titration; W 2-3 dose adjust to optimal level；Week 4-6：stable dose	Drug	HS-10380 Low Dose
HS-10380 Medium doseW1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose	Drug	HS-10380 Medium dose
HS-10380 High DoseW1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose	Drug	HS-10380 High Dose
AripiprazoleW1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose	Drug	Aripiprazole
PlaceboW1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose	Drug	Placebo

Primary outcome

Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42)
Time frame: Baseline and Week 6
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

5 secondary outcomes

Percentage of Positive and Negative Syndrome Scale (PANSS) Responders (>=40% Change in PANSS Total Score) at Day 42
Time frame: Baseline and Week 6
Change in Marder 5-factor score of the PANSS scale at Day 42 compared with baseline
Time frame: Baseline and Week 6
Change in Calgary Depression Scale for Schizophrenia (CDSS) score at Day 42 compared with baseline
Time frame: Baseline and Week 6
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 42
Time frame: Baseline and Week 6
Clinical Global Impression-Improvement (CGI-I) Score at Day 42
Time frame: Week 1 and Week 6

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.

Related trials for SCHIZOPHRENIA 1 (Disorder)

Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
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

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HS-10380 Low Dose, HS-10380 Medium dose and HS-10380 High Dose 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 12 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: finished, as of the sponsor's last update on 24 Apr 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42) (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07550387.

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 24 Apr 2026.