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Safety, Tolerability, Pharmacokinetics and Efficacy Study of HS-10380 in Patients With Schizophrenia

NCT05964790 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2023-07-28

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10380 relative to placebo for the treatment of participants with schizophrenia.

Conditions

Interventions

DRUG

HS-10380

Participants in arm HS-10380 will receiving multiple ascending doses of HS-10380 (1.5 mg initial dose) orally once daily for 28 days

DRUG

Placebo

Participants in arm Placebo will receiving multiple ascending doses of Placebo matching HS-10380 (1.5 mg initial dose) orally once daily for 28 days

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-30
Primary Completion
2024-06-30
Completion
2024-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05964790 on ClinicalTrials.gov