SchizophreniaPhase 1/2NCT05964790
Safety, Tolerability, Pharmacokinetics and Efficacy Study of HS-10380 in Patients With Schizophrenia
A Phase 1/2 study testing HS-10380 in people with Schizophrenia, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- HS-10380
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2023to 30 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Phase Ⅰb/Ⅱ, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10380 in Chinese Adults With Schizophrenia.
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.
Read the 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 with schizophrenia, and the primary aim of expansion cohorts is to evaluate efficacy of HS-10380 in participants with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- HS-10380, Placebo
- Keywords
- Schizophrenia, Psychotropic drug, Antipsychotic agents
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10380Drug
Participants in arm HS-10380 will receiving multiple ascending doses of HS-10380 (1.5 mg initial dose) orally once daily for 28 days
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| HS-10380 | Experimental | Participants received HS-10380 tablet orally once daily for 28 days. Receives: Drug: HS-10380 |
| Placebo | Placebo comparator | Participants received placebo tablet matching HS-10380 1.5mg tablet orally once daily for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation cohorts: Incidence and severity of adverse events(AE) ，serious AEs and AE leading to withdrawal from treatment.
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.
Measured: Baseline to Day 43
Dose escalation cohorts: Changes from baseline in complete blood count (CBC).
Hematology parameters to be reported: white blood cells, red blood cells and platelets.
Measured: Baseline to Day 36
Dose escalation cohorts: Changes from baseline in urinalysis.
Parameters to be reported: protein, glucose, ketones, red blood cells, and white blood cells.
Measured: Baseline to Day 36
Dose escalation cohorts: Changes from baseline in blood biochemistry test.
Parameters to be reported: glucose, urea, serum creatinine, alanine aminotransferase, aspartate transaminase, albumin, total protein, bilirubin, and blood lipid index.
Measured: Baseline to Day 36
Dose escalation cohorts: Changes from baseline in coagulation function test.
prothrombin time, activated partial thromboplastin time and international normalized ratio.
Measured: Baseline to Day 36
Dose escalation cohorts: Changes from baseline in thyroid function test.
thyroxine, triiodothyronine, free triiodothyronine, free thyroxin and thyroid stimulating hormone.
Measured: Baseline to Day 36
Dose escalation cohorts: Changes from baseline in serum prolactin.
Laboratory test.
Measured: Baseline to Day 36
Dose escalation cohorts: Changes from baseline in blood pressure (BP).
Vital sign.
Measured: Baseline to Day 36
Dose escalation cohorts: Changes from baseline in pulse rate.
Vital sign.
Measured: Baseline to Day 36
Dose escalation cohorts: Changes from baseline in body temperature.
Vital sign.
Measured: Baseline to Day 36
Dose escalation cohorts: Change from baseline in body weight
Body weight was measured in kilograms (Kg).
Measured: Baseline to Day 29
Dose escalation cohorts: Change from baseline in Electrocardiogram (ECG)
ECG parameters including heart rate, PR interval, RR interval and QTcF, etc.
Measured: Baseline to Day 36
Dose escalation cohorts: Change from baseline in Simpson-Angus Scale (SAS)
SAS is a 10-item testing instrument used to evaluate drug-related extrapyramidal syndromes. The following items are included in the SAS: gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella reflex, tremor, and salivation. Total score ranges from 0 to 40 with a higher score indicating increased severity.
Measured: Baseline to Day 36
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
AIMS is a rating scale measuring involuntary movements known as tardive dyskinesia, that sometimes develop as a side effect of long-term treatment with antipsychotic medications. The AIMS score was calculated as the sum of questions 1 through 7 of the AIMS instrument, which includes assessments of involuntary movements in the face, lips, jaw, tongue, upper and lower extremities, and neck/shoulders/hips. Each item is rated on a five-point scale of severity from 0-4 with 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Total scores range from 0 to 28.
Measured: Baseline to Day 36
Dose escalation cohorts: Change from baseline in Barnes Akathisia Rating Scale
BARS is a rating scale that is administered by physicians to assess the severity of drug-induced akathisia, which is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. The following subcategories are scored: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness and are rated on a 4-point scale from 0-3. In addition, the global clinical assessment of akathisia uses a 6-point scale ranging from 0-5. Total score ranges from 0 to 14 with a higher score indicating increased severity.
Measured: Baseline to Day 36
Dose escalation cohorts: Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors, and has a binary response (yes/no). Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent. Suicidal Behavior: a "yes" answer to any of 5 suicidal behavior questions: Preparatory Acts or Behavior, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide.
Measured: Baseline to Day 36
Expansion cohorts: Change from Baseline in Positive and Negative Syndrome Scale (PANSS)
PANSS is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.
Measured: Baseline to Day 28
Expansion cohorts: Positive and Negative Syndrome Scale (PANSS) Response at Week 4, Defined as a 20% or Greater Improvement from Baseline in PANSS Total Score
PANSS is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.
Measured: Baseline to Day 28
Expansion cohorts: Change from Baseline in Clinical Global Impression-Severity (CGI-S)
CGI-S is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed.
The CGI-S a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.
Measured: Baseline to Day 28
Secondary outcomes (29)
Dose escalation cohorts: Maximum plasma concentration (Cmax) of first HS-10380 administration
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing.
Measured: Baseline to Day 36
Dose escalation cohorts: Time of the Maximum Concentration (Tmax) of first HS-10380 administration
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing.
Measured: Baseline to Day 36
Dose escalation cohorts: Area under the concentration time curve of intervals (AUC0-τ) of first HS-10380 administration
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing.
Measured: Baseline to Day 36
Dose escalation cohorts: Area under the concentration time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t) of first HS-10380 administration
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing.
Measured: Baseline to Day 36
Dose escalation cohorts: Maximum concentration at steady state (Css, max) of multiple-dose HS-10380 administration
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing.
Measured: Baseline to Day 36
Dose escalation cohorts: Time of the maximum concentration at steady state (Tss, max) of multiple-dose HS-10380 administration
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing.
Measured: Baseline to Day 36
Dose escalation cohorts: Minimum concentration at steady state (Css, min) of multiple-dose HS-10380 administration
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing.
Measured: Baseline to Day 36
Dose escalation cohorts: Area under the concentration-time curve at steady state (AUCss) of multiple-dose HS-10380 administration
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing.
Measured: Baseline to Day 36
Dose escalation cohorts: Apparent clearance at steady state (CLss/F) of multiple-dose HS-10380 administration
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing.
Measured: Baseline to Day 36
Dose escalation cohorts: Apparent volume of distribution at steady state (Vss/F) of multiple-dose HS-10380 administration
Pharmacokinetics describes the action of a drug in the body over a period of time. Blood samples are collected to measure plasma concentrations of the study drug at different times after dosing.
Measured: Baseline to Day 36
Dose escalation cohorts: Change from Baseline in Positive and Negative Syndrome Scale (PANSS)
PANSS is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.
Measured: Baseline to Day 28
Dose escalation cohort: Positive and Negative Syndrome Scale (PANSS) Response at Week 4, Defined as a 20% or Greater Improvement from Baseline in PANSS Total Score
PANSS is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.
Measured: Baseline to Day 28
Dose escalation cohorts: Change from Baseline in Clinical Global Impression-Severity (CGI-S)
CGI-S is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed.
The CGI-S a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.
Measured: Baseline to Day 28
Expansion cohorts: Incidence and severity of adverse events(AE) ，serious AEs and AE leading to withdrawal from treatment.
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.
Measured: Baseline to Day 43
Expansion cohorts: Changes from baseline in complete blood count (CBC).
Hematology parameters to be reported: white blood cells, red blood cells and platelets.
Measured: Baseline to Day 36
Expansion cohorts: Changes from baseline in urinalysis.
Parameters to be reported: protein, glucose, ketones, red blood cells, and white blood cells.
Measured: Baseline to Day 36
Expansion cohorts: Changes from baseline in blood biochemistry test.
Parameters to be reported: glucose, urea, serum creatinine, alanine aminotransferase, aspartate transaminase, albumin, total protein, bilirubin, and blood lipid index.
Measured: Baseline to Day 36
Expansion cohorts: Changes from baseline in coagulation function test
prothrombin time, activated partial thromboplastin time and international normalized ratio.
Measured: Baseline to Day 36
Expansion cohorts: Changes from baseline in hyroid function test
thyroxine, triiodothyronine, free triiodothyronine, free thyroxin and thyroid stimulating hormone.
Measured: Baseline to Day 36
Expansion cohorts: Changes from baseline in serum prolactin
Laboratory test.
Measured: Baseline to Day 36
Expansion cohorts: Changes from baseline in blood pressure (BP)
Vital sign.
Measured: Baseline to Day 36
Expansion cohorts: Changes from baseline in pulse rate
Vital sign.
Measured: Baseline to Day 36
Expansion cohorts: Changes from baseline in body temperature
Vital sign.
Measured: Baseline to Day 36
Expansion cohorts: Change from baseline in body weight
Body weight was measured in kilograms (Kg).
Measured: Baseline to Day 29
Expansion cohorts: Change from baseline in Electrocardiogram (ECG)
ECG parameters including heart rate, PR interval, RR interval and QTcF, etc.
Measured: Baseline to Day 36
Expansion cohorts: Change from baseline in Simpson-Angus Scale (SAS)
SAS is a 10-item testing instrument used to evaluate drug-related extrapyramidal syndromes. The following items are included in the SAS: gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella reflex, tremor, and salivation. Total score ranges from 0 to 40 with a higher score indicating increased severity.
Measured: Baseline to Day 36
Expansion cohorts: Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
AIMS is a rating scale measuring involuntary movements known as tardive dyskinesia, that sometimes develop as a side effect of long-term treatment with antipsychotic medications. The AIMS score was calculated as the sum of questions 1 through 7 of the AIMS instrument, which includes assessments of involuntary movements in the face, lips, jaw, tongue, upper and lower extremities, and neck/shoulders/hips. Each item is rated on a five-point scale of severity from 0-4 with 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Total scores range from 0 to 28.
Measured: Baseline to Day 36
Expansion cohorts: Change from baseline in Barnes Akathisia Rating Scale
BARS is a rating scale that is administered by physicians to assess the severity of drug-induced akathisia, which is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. The following subcategories are scored: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness and are rated on a 4-point scale from 0-3. In addition, the global clinical assessment of akathisia uses a 6-point scale ranging from 0-5. Total score ranges from 0 to 14 with a higher score indicating increased severity.
Measured: Baseline to Day 36
Expansion cohorts: Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors, and has a binary response (yes/no). Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent. Suicidal Behavior: a "yes" answer to any of 5 suicidal behavior questions: Preparatory Acts or Behavior, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide.
Measured: Baseline to Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start30 Jul 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964790
- Sponsor's protocol ID
- HS-10380-201
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰb/Ⅱ, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10380 in Chinese Adults With Schizophrenia.
- ClinicalTrials.gov ID
- NCT05964790
- Acronym / sponsor ID
- HS-10380-201
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Psychotropic drug, Antipsychotic agents
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 with schizophrenia, and the primary aim of expansion cohorts is to evaluate efficacy of HS-10380 in participants with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10380 | Experimental | Drug: HS-10380Participants received HS-10380 tablet orally once daily for 28 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo tablet matching HS-10380 1.5mg tablet orally once daily for 28 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Dose escalation 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.
Key exclusion criteria (45 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10380Participants in arm HS-10380 will receiving multiple ascending doses of HS-10380 (1.5 mg initial dose) orally once daily for 28 days | Drug | HS-10380 |
| PlaceboParticipants in arm Placebo will receiving multiple ascending doses of Placebo matching HS-10380 (1.5 mg initial dose) orally once daily for 28 days | Drug | Placebo |
Primary outcome
Dose escalation cohorts: Incidence and severity of adverse events(AE) ，serious AEs and AE leading to withdrawal from treatment.
Time frame: Baseline to Day 43
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.
Dose escalation cohorts: Changes from baseline in complete blood count (CBC).
Time frame: Baseline to Day 36
Hematology parameters to be reported: white blood cells, red blood cells and platelets.
Dose escalation cohorts: Changes from baseline in urinalysis.
Time frame: Baseline to Day 36
Parameters to be reported: protein, glucose, ketones, red blood cells, and white blood cells.
Dose escalation cohorts: Changes from baseline in blood biochemistry test.
Time frame: Baseline to Day 36
Parameters to be reported: glucose, urea, serum creatinine, alanine aminotransferase, aspartate transaminase, albumin, total protein, bilirubin, and blood lipid index.
Dose escalation cohorts: Changes from baseline in coagulation function test.
Time frame: Baseline to Day 36
prothrombin time, activated partial thromboplastin time and international normalized ratio.
Dose escalation cohorts: Changes from baseline in thyroid function test.
Time frame: Baseline to Day 36
thyroxine, triiodothyronine, free triiodothyronine, free thyroxin and thyroid stimulating hormone.
Dose escalation cohorts: Changes from baseline in serum prolactin.
Time frame: Baseline to Day 36
Laboratory test.
Dose escalation cohorts: Changes from baseline in blood pressure (BP).
Time frame: Baseline to Day 36
Vital sign.
Dose escalation cohorts: Changes from baseline in pulse rate.
Time frame: Baseline to Day 36
Vital sign.
Dose escalation cohorts: Changes from baseline in body temperature.
Time frame: Baseline to Day 36
Vital sign.
Dose escalation cohorts: Change from baseline in body weight
Time frame: Baseline to Day 29
Body weight was measured in kilograms (Kg).
Dose escalation cohorts: Change from baseline in Electrocardiogram (ECG)
Time frame: Baseline to Day 36
ECG parameters including heart rate, PR interval, RR interval and QTcF, etc.
Dose escalation cohorts: Change from baseline in Simpson-Angus Scale (SAS)
Time frame: Baseline to Day 36
SAS is a 10-item testing instrument used to evaluate drug-related extrapyramidal syndromes. The following items are included in the SAS: gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella reflex, tremor, and salivation. Total score ranges from 0 to 40 with a higher score indicating increased severity.
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: Baseline to Day 36
AIMS is a rating scale measuring involuntary movements known as tardive dyskinesia, that sometimes develop as a side effect of long-term treatment with antipsychotic medications. The AIMS score was calculated as the sum of questions 1 through 7 of the AIMS instrument, which includes assessments of involuntary movements in the face, lips, jaw, tongue, upper and lower extremities, and neck/shoulders/hips. Each item is rated on a five-point scale of severity from 0-4 with 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Total scores range from 0 to 28.
Dose escalation cohorts: Change from baseline in Barnes Akathisia Rating Scale
Time frame: Baseline to Day 36
BARS is a rating scale that is administered by physicians to assess the severity of drug-induced akathisia, which is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. The following subcategories are scored: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness and are rated on a 4-point scale from 0-3. In addition, the global clinical assessment of akathisia uses a 6-point scale ranging from 0-5. Total score ranges from 0 to 14 with a higher score indicating increased severity.
Dose escalation cohorts: Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline to Day 36
C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors, and has a binary response (yes/no). Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent. Suicidal Behavior: a "yes" answer to any of 5 suicidal behavior questions: Preparatory Acts or Behavior, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide.
Expansion cohorts: Change from Baseline in Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline to Day 28
PANSS is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.
Expansion cohorts: Positive and Negative Syndrome Scale (PANSS) Response at Week 4, Defined as a 20% or Greater Improvement from Baseline in PANSS Total Score
Time frame: Baseline to Day 28
PANSS is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.
Expansion cohorts: Change from Baseline in Clinical Global Impression-Severity (CGI-S)
Time frame: Baseline to Day 28
CGI-S is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The CGI-S a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.
29 secondary outcomes
Dose escalation cohorts: Maximum plasma concentration (Cmax) of first HS-10380 administration
Time frame: Baseline to Day 36
Dose escalation cohorts: Time of the Maximum Concentration (Tmax) of first HS-10380 administration
Time frame: Baseline to Day 36
Dose escalation cohorts: Area under the concentration time curve of intervals (AUC0-τ) of first HS-10380 administration
Time frame: Baseline to Day 36
Dose escalation cohorts: Area under the concentration time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t) of first HS-10380 administration
Time frame: Baseline to Day 36
Dose escalation cohorts: Maximum concentration at steady state (Css, max) of multiple-dose HS-10380 administration
Time frame: Baseline to Day 36
Dose escalation cohorts: Time of the maximum concentration at steady state (Tss, max) of multiple-dose HS-10380 administration
Time frame: Baseline to Day 36
Dose escalation cohorts: Minimum concentration at steady state (Css, min) of multiple-dose HS-10380 administration
Time frame: Baseline to Day 36
Dose escalation cohorts: Area under the concentration-time curve at steady state (AUCss) of multiple-dose HS-10380 administration
Time frame: Baseline to Day 36
Dose escalation cohorts: Apparent clearance at steady state (CLss/F) of multiple-dose HS-10380 administration
Time frame: Baseline to Day 36
Dose escalation cohorts: Apparent volume of distribution at steady state (Vss/F) of multiple-dose HS-10380 administration
Time frame: Baseline to Day 36
Dose escalation cohorts: Change from Baseline in Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline to Day 28
Dose escalation cohort: Positive and Negative Syndrome Scale (PANSS) Response at Week 4, Defined as a 20% or Greater Improvement from Baseline in PANSS Total Score
Time frame: Baseline to Day 28
Dose escalation cohorts: Change from Baseline in Clinical Global Impression-Severity (CGI-S)
Time frame: Baseline to Day 28
Expansion cohorts: Incidence and severity of adverse events(AE) ，serious AEs and AE leading to withdrawal from treatment.
Time frame: Baseline to Day 43
Expansion cohorts: Changes from baseline in complete blood count (CBC).
Time frame: Baseline to Day 36
Expansion cohorts: Changes from baseline in urinalysis.
Time frame: Baseline to Day 36
Expansion cohorts: Changes from baseline in blood biochemistry test.
Time frame: Baseline to Day 36
Expansion cohorts: Changes from baseline in coagulation function test
Time frame: Baseline to Day 36
Expansion cohorts: Changes from baseline in hyroid function test
Time frame: Baseline to Day 36
Expansion cohorts: Changes from baseline in serum prolactin
Time frame: Baseline to Day 36
Expansion cohorts: Changes from baseline in blood pressure (BP)
Time frame: Baseline to Day 36
Expansion cohorts: Changes from baseline in pulse rate
Time frame: Baseline to Day 36
Expansion cohorts: Changes from baseline in body temperature
Time frame: Baseline to Day 36
Expansion cohorts: Change from baseline in body weight
Time frame: Baseline to Day 29
Expansion cohorts: Change from baseline in Electrocardiogram (ECG)
Time frame: Baseline to Day 36
Expansion cohorts: Change from baseline in Simpson-Angus Scale (SAS)
Time frame: Baseline to Day 36
Expansion cohorts: Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: Baseline to Day 36
Expansion cohorts: Change from baseline in Barnes Akathisia Rating Scale
Time frame: Baseline to Day 36
Expansion cohorts: Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline to Day 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HS-10380 in people with Schizophrenia, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose escalation cohorts: Incidence and severity of adverse events(AE) ，serious AEs and AE leading to withdrawal from treatment. (time frame: Baseline to Day 43). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.