HS-10380 Phase 2b Schizophrenia Efficacy Trial, Hospitalized Adults
Summary
This ClinicalTrials.gov registry entry documents a Phase 2b randomized, double-blind, parallel-group, active-controlled and placebo-controlled multicenter inpatient study (NCT07550387) evaluating HS-10380 in adult patients with DSM-5 schizophrenia who are acutely psychotic. The study employs three HS-10380 dose arms (Low, Medium, High) alongside an Aripiprazole active comparator and placebo. The primary endpoint is reduction in Positive and Negative Syndrome Scale (PANSS) total scores versus placebo; secondary endpoints include response rate, symptom improvement, safety, tolerability, and pharmacokinetics. As a registry entry, this document does not create compliance obligations but informs pharmaceutical manufacturers and investors about a drug candidate in early clinical development.
“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.”
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What changed
This ClinicalTrials.gov entry registers a Phase 2b multicenter inpatient study (NCT07550387) examining the efficacy and safety of HS-10380 in adult patients with acute schizophrenia. The study is randomized, double-blind, parallel-group, and employs both placebo and Aripiprazole as comparators across three HS-10380 dose levels. Primary outcome measures reduction in PANSS total scores; secondary assessments include response rate, symptom improvement, safety, tolerability, and pharmacokinetics.
Pharmaceutical manufacturers and clinical researchers should note that this registry entry represents early-phase drug development activity in the antipsychotic space. The study does not impose regulatory obligations on third parties; rather, it serves as an informational record of planned clinical investigation. Investors and competitors in the CNS therapeutic area may use this entry to track pipeline activity for HS-10380.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study Assessing the Efficacy and Safety of HS-10380 in Hospitalized Adults With Acute Schizophrenia
Phase 2 NCT07550387 Kind: PHASE2 Apr 24, 2026
Abstract
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)
Interventions: HS-10380 Low Dose, HS-10380 Medium dose, HS-10380 High Dose, Aripiprazole, Placebo
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