CompletedPhase 2

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

China363 participantsStarted 2024-05-23

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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-act…

What they're measuring

Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42)

Timeframe: Baseline and Week 6

Trial details

NCT IDNCT07550387

SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-02