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

NCT07550387 | Completed Phase 2

• 1 other identifier: HS-10380-202
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SCHIZOPHRENIA 1 (Disorder)

Keywords

Schizophrenia, PANSS, HS-10380

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline and Week 6

• Change in Marder 5-factor score of the PANSS scale at Day 42 compared with baseline

  Baseline and Week 6

• Change in Calgary Depression Scale for Schizophrenia (CDSS) score at Day 42 compared with baseline

  Baseline and Week 6

• Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 42

  Baseline and Week 6

• Clinical Global Impression-Improvement (CGI-I) Score at Day 42

  Week 1 and Week 6

Study Arms (5)

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

Interventions

HS-10380 Low Dose DRUG

W1：dose titration; W 2-3 dose adjust to optimal level；Week 4-6：stable dose

HS-10380 Low Dose

HS-10380 Medium dose DRUG

W1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose

HS-10380 Medium dose

HS-10380 High Dose DRUG

W1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose

HS-10380 High Dose

Aripiprazole DRUG

W1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose

Aripiprazole

Placebo DRUG

W1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose

Placebo

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.
• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 24, 2026
• Study Start: May 23, 2024
• Primary Completion: January 2, 2026
• Study Completion: January 19, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)