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

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.

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.

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.