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Status:

UNKNOWN

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

Lead Sponsor:

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Conditions:

Schizophrenia

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

PHASE2

Brief 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.

Detailed Description

The trial consists of two parts: dose escalation cohorts and expansion cohorts. The primary aim of the dose escalation cohorts is to evaluate the safety and tolerability of HS-10380 in participants wi...

Eligibility Criteria

Inclusion

  • Dose escalation cohorts:
  • Patients are 18 to 55 years of age, inclusive.
  • Body mass index (BMI) between 18.5 and 30.0 kg/m2 ,inclusive. Weight ≥ 50 kg for male subjects and ≥ 45 kg for female subjects.
  • Patient meets DSM-5 criteria for schizophrenia.
  • Currently not taking antipsychotics. Or on a stable dose of single second-generation antipsychotics (SGA) for at least 2 weeks, limited to either risperidone, olanzapine, quetiapine, aripiprazole, or paliperidone.
  • PANSS total score ≤ 90. Rating ≤ 4 on hostility and uncooperativeness,
  • Negative urine pregnancy test (women of childbearing potential only).
  • Male and female patients must agree to use a highly effective method of birth control during the course of the entire study and for 3 months after the last dose of investigational product.
  • Written informed consent has been obtained.
  • Expansion cohorts:
  • Patients are 18 to 65 years of age, inclusive.
  • Patient meets DSM-5 criteria for schizophrenia.
  • No current use of antipsychotics. Or withdrawing from antipsychotics other than clozapine for more than 5 half-lives prior to randomization.
  • PANSS total score ≥70 and ≤120. Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behavior; P6: suspiciousness/persecution.
  • Negative urine pregnancy test (women of childbearing potential only).
  • Male and female patients must agree to use a highly effective method of birth control during the course of the entire study and for 3 months after the last dose of investigational product.
  • Written informed consent has been obtained.

Exclusion

  • Dose escalation cohorts:
  • Patients meet DSM-5 criteria for a mental illness other than schizophrenia, and might interfere with the conduct of the study as determined by the investigator.
  • Current risk of self-harm or violence, including: having any suicidal ideation or suicidal behavior within the last 6 months, as assessed using Columbia-Suicidal Severity Rating Scale (C-SSRS).
  • Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder, etc. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with the conduct of the study.
  • Patients who received electroconvulsive therapy (ECT) within 3 months prior to screening.
  • Received a long-acting antipsychotic within 6 months prior to screening or within the duration of 5 half-lives of the drug.
  • History of seizure disorder (with the exception of febrile seizure).
  • History of malignant syndrome.
  • Any condition that would be expected to affect drug absorption, distribution, metabolism and excretion, including gastrointestinal surgery, urinary tract obstruction or difficulty in urination, etc.
  • History of severe allergies.
  • Female patients who are pregnant, puerperal or breastfeeding.
  • History of drug addiction within 1 year prior to screening.
  • Patients who has a history of alcohol abuse (defined as more than 14 standard units of alcohol consumption per week, 1 standard unit = 360 mL of beer, 45 mL of distilled spirits or 150 mL of wine) within 6 months prior to screening, or are unable to abstain from alcohol use during the study period.
  • Patients who smoke ≥10 cigarettes per day within 3 months prior to screening, or are unable to quit smoking during the study period.
  • Abnormal physical examination results that may interfere with the study.
  • Abnormal vital signs that may interfere with the study, including: resting heart rate \<60 or \>100 beats per minute, systolic blood pressure \<90mmHg or ≥140mmHg, diastolic blood pressure \<60mmHg or ≥90mmHg.
  • Abnormal electrocardiogram (ECG) results may interfere with the study, including: QTcF\>450ms for male subjects and \>470ms for female subjects based on Fridericia correction.
  • Abnormal clinical laboratory test results may interfere with the study, including: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) results \>1.5 × the upper limit of normal (ULN); serum prolactin levels \>5 × ULN or significant clinical symptoms like amenorrhea, gynecomastia, and lactation.
  • Patients whose results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or syphilis serological reaction (TRUST) is not negative.
  • Blood donation or blood loss ≥ 200ml within 1 month prior to screening.
  • Patients requiring concomitant treatment with a moderate or strong cytochrome P450 (CYP) 3A4 inhibitors or CYP3A4 inducers, or a moderate or strong cytochrome CYP2D6 inhibitors or CYP3A4 inducers.
  • Prior participation in any Interventional clinical trials within 3 months.
  • Unsuitable for any other reason, as judged by the investigator.
  • Expansion cohorts:
  • Patients meet DSM-5 criteria for a mental illness other than schizophrenia, and might interfere with the conduct of the study as determined by the investigator.
  • Current risk of self-harm or violence, including: having any suicidal ideation or suicidal behavior within the last 6 months, as assessed using Columbia-Suicidal Severity Rating Scale (C-SSRS).
  • Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder, etc. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with the conduct of the study.
  • Patients who received electroconvulsive therapy (ECT) within 3 months prior to screening.
  • Received a long-acting antipsychotic within 6 months prior to screening or within the duration of 5 half-lives of the drug.
  • History of seizure disorder (with the exception of febrile seizure).
  • History of malignant syndrome.
  • Any condition that would be expected to affect drug absorption, distribution, metabolism and excretion, including gastrointestinal surgery, urinary tract obstruction or difficulty in urination, etc.
  • History of severe allergies.
  • Female patients who are pregnant, puerperal or breastfeeding.
  • History of drug addiction within 1 year prior to screening.
  • Patients who has a history of alcohol abuse (defined as more than 14 standard units of alcohol consumption per week, 1 standard unit = 360 mL of beer, 45 mL of distilled spirits or 150 mL of wine) within 6 months prior to screening, or are unable to abstain from alcohol use during the study period.
  • Abnormal physical examination results that may interfere with the study.
  • Abnormal vital signs that may interfere with the study, including: resting heart rate \<60 or \>100 beats per minute, systolic blood pressure \<90mmHg or ≥140mmHg, diastolic blood pressure \<60mmHg or ≥90mmHg.
  • Abnormal electrocardiogram (ECG) results may interfere with the study, including: QTcF\>450ms for male subjects and \>470ms for female subjects based on Fridericia correction.
  • Abnormal clinical laboratory test results may interfere with the study, including: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) results \> 2 × the upper limit of normal (ULN).
  • Patients whose results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or syphilis serological reaction (TRUST) is not negative.
  • Patients requiring concomitant treatment with a moderate or strong cytochrome P450 (CYP) 3A4 inhibitors or CYP3A4 inducers, or a moderate or strong cytochrome CYP2D6 inhibitors or CYP3A4 inducers.
  • Blood donation or blood loss ≥ 200ml within 1 month prior to screening.
  • Prior participation in any Interventional clinical trials within 3 months.
  • Unsuitable for any other reason, as judged by the investigator.

Key Trial Info

Start Date :

July 30 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2024

Estimated Enrollment :

112 Patients enrolled

Trial Details

Trial ID

NCT05964790

Start Date

July 30 2023

End Date

December 30 2024

Last Update

July 28 2023

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