- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05192304
Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TPN672 Tablets Maleate in Patients With Schizophrenia (TPN672)
December 30, 2021 updated by: Jiangsu Kanion Pharmaceutical Co., Ltd
A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Multiple Doses of TPN672 Tablets Maleate in Patients With Schizophrenia
This is a Phase Ib clinical study of TPN672 maleate in patients with schizophrenia
Study Overview
Detailed Description
This is a single-center, randomized, double-blind, placebo-controlled, dosion-increasing, Phase Ib clinical study evaluating the safety, tolerability, and pharmacokinetic characteristics of multiple doses of TPN672 maleate in patients with schizophrenia
Study Type
Interventional
Enrollment (Anticipated)
62
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhao Binjiang
- Phone Number: 86-518-85521987
- Email: 13466570402@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200030
- Shanghai Mental Health Center
-
Contact:
- LI Huafang
- Phone Number: 86-21-34773107
- Email: lhlh_5@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years old ≤ age ≤ 65 years old at the time of signing the informed consent form, male or female.
- 18.5kg/m2 ≤ body mass index (BMI) ≤ 30kg/m2, and weight ≥ 50kg for men and ≥ 45kg for women.
- Subjects met DSM-5 diagnostic criteria for a confirmed diagnosis of schizophrenia and were stable within the past 6 months as assessed by the investigator.
- Subjects are currently taking aripiprazole, olanzapine or risperidone monotherapy for schizophrenia at a dose not exceeding the maximum dose specified in the instructions and the dose and frequency of administration have not changed in the last 1 month.
- Screening period PANSS scale total score <70, PANSS scale individual score of positive symptom items ≤3, CGI-S score ≤4.
- Individual scores were ≤1 on the SAS scale, ≤2 on the AIMS scale, and ≤2 on item 4 of the BARS scale, "Overall clinical assessment of sedentary inability" during the screening period.
- Female and male subjects of childbearing potential and their spouses must be able to secure effective contraception (medically approved contraception such as IUDs, the pill or condoms) during the study and for 6 months after the end of the drug administration.
- Subjects and their guardians fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign a written informed consent form, and are willing to complete the entire trial process according to the trial requirements.
Exclusion Criteria:
- Subjects met DSM-5 criteria for other psychiatric disorders.
- Subjects were administered strong inducers/strong inhibitors of CYP2D6, CYP3A4, CYP3A5, CYP2C9 for 5 half-lives prior to the first dose.
- Subjects were on long-acting antipsychotics for 6 months prior to their first dose.
- Received electroconvulsive therapy, transcranial magnetic stimulation (rTMS) within 1 month prior to screening
- Those who answered "yes" to questions 4 or 5 of the suicidal ideation entry on the Columbia Suicide Scale (C-SSRS) during the screening period, or who were currently or within the past 12 months significantly suicidal, or who were considered to be at risk for suicidal and violent behavior based on the investigator's clinical assessment.
- Those with abnormal physical examination or vital signs during the screening period that are clinically significant.
- Abnormal laboratory tests during the screening period that the investigator determines to be clinically significant, e.g., liver: ALT or AST≥ 1.2 times the upper limit of normal; kidney: Cr> the upper limit of normal value.
- Prolactin ≥ 5 times the upper limit of normal during the screening period.
- Screening subjects with systolic blood pressure <90 mmHg or >140 mmHg and diastolic blood pressure < 60mmHg or >90mmHg.
- Patients with poorly controlled diabetes (fasting glucose ≥ 10 mmol/L), or are On insulin for diabetes, or at screening with a primary diagnosis of type 2 diabetes.
- Screening QTc interval >450ms (men) or 470ms (women), or family history of long QT interval syndrome, or combined cardiac insufficiency, severe arrhythmia or ischemic heart disease requiring medication, congenital heart disease, severe organic heart disease or history of such disease.
- Combined with convulsive disorders such as epilepsy (except febrile convulsions)
- Current or previous hyper- or hypothyroidism, Parkinson's disease, malignancy.
- Tobacco addiction within 1 year prior to screening, with an average of >10 cigarettes or equivalent per day.
- Alcohol consumption within 1 year prior to screening, with an average weekly intake of more than 14 units of alcohol (1 unit = 285 ml of beer or 25 ml of spirits or 150 ml of wine) or a positive breath test for alcohol.
- Persons with a history of drug or substance abuse within 1 year prior to screening or a positive urine drug screen.
- Subjects who may be hypersensitive to any of the components of this drug.
- HIV antibody, HBsAg, HCV antibody or positive syphilis serology results.
- History of significant blood loss or blood loss ≥ 200 ml in the 3 months prior to screening
- Enrolled in another clinical trial within 3 months prior to screening, or currently participating in a clinical trial.
- Women who are expecting or breastfeeding.
- The investigator did not consider it appropriate to participate in this trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.2mg single dose
single dose of TPN-672 0.2mg, 2 subjects
|
single dose of TPN-672 maleate tablet
Other Names:
|
Experimental: 0.3mg single dose
single dose of TPN-672 0.3mg, 12 subjects(9 for TPN-672, 3 for placebo)
|
single dose of TPN-672 maleate tablet
Other Names:
|
Experimental: 0.4mg single dose
single dose of TPN-672 0.4mg, 12 subjects(9 for TPN-672, 3 for placebo)
|
single dose of TPN-672 maleate tablet
Other Names:
|
Experimental: 0.5mg single dose
single dose of TPN-672 0.5mg, 12 subjects(9 for TPN-672, 3 for placebo)
|
single dose of TPN-672 maleate tablet
Other Names:
|
Experimental: 0.6mg single dose
single dose of TPN-672 0.6mg, 12 subjects(9 for TPN-672, 3 for placebo)
|
single dose of TPN-672 maleate tablet
Other Names:
|
Experimental: 0.7mg single dose
single dose of TPN-672 0.7mg, 12 subjects(9 for TPN-672, 3 for placebo)
|
single dose of TPN-672 maleate tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: follow-up visit from the beginning of the dose to the day 14 after the last dose
|
Incidence of Adverse Events
|
follow-up visit from the beginning of the dose to the day 14 after the last dose
|
Blood pressure
Time Frame: Day 14
|
Safety indicator,Blood pressure is recorded in millimeters of mercury
|
Day 14
|
Respiration
Time Frame: Day 14
|
Safety indicator,the unit of recording is the number of breaths per minute.
|
Day 14
|
Heart rate
Time Frame: Day 14
|
Safety indicator,the unit of heart rate is the number of heartbeats per minute.
|
Day 14
|
Temperature
Time Frame: Day 14
|
Safety indicator,Body temperature is recorded in degrees Celsius
|
Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum plasma concentration (Cmax)
Time Frame: 240 hours
|
Blood will be drawn from adult subjects pre-drug application and at 30min, 60min, 90min, 120min, 180min, 240min (4h), 480min (8h),720min (12h),1440min(24h).
|
240 hours
|
Time to maximum plasma concentration (Tmax)
Time Frame: 240 hours
|
Biological sample including blood for PK will be collected at the same time point.
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240 hours
|
Area under the curve (AUC)
Time Frame: 240 hours
|
Biological sample including blood for PK will be collected at the same time point.
|
240 hours
|
steady state minimal concentration(Css_min)
Time Frame: 240hours
|
Biological sample including blood for PK will be collected at the same time point
|
240hours
|
Elimination half-life (t1/2)
Time Frame: 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours ,days 8-14 after the last dose.
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Biological sample including blood for PK will be collected at the same time point.
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30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours ,days 8-14 after the last dose.
|
Positive and Negative Syndrome Scale
Time Frame: Follow-up visit on the day 14 after the last dose
|
The PANSS consisted of a positive scale of 7 items, a negative scale of 7 items, and a general psychopathology scale of 16 items, for a total of 30 items, and 3 supplementary items to assess the risk of attack.
A 7-point scale with increasing levels of psychopathology was used: 1 nothing; 7 a very severe.
|
Follow-up visit on the day 14 after the last dose
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Clinical Global Impression sions scale
Time Frame: Follow-up visit on the day 14 after the last dose
|
The scale is divided into 1.
overall assessment of disease severity 2. overall degree of improvement.
The lower the score, the higher the degree of improvement of the patient.
|
Follow-up visit on the day 14 after the last dose
|
Calgary Depression Scale for Schizophrenia
Time Frame: Follow-up visit on the day 14 after the last dose
|
There were 9 entries, including mood depression, feelings of hopelessness, self-deprecation, guilt implicated perceptions, pathological guilt, morning depression, early awakening, suicidality, and observed depressive manifestations.
The lower the score the less severe the depressive symptoms.
|
Follow-up visit on the day 14 after the last dose
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Blood coagulation function
Time Frame: Day 14
|
Safety indicators, including PT,APTT
|
Day 14
|
12-lead ECG
Time Frame: Day 14
|
Safety indicators, including QTc
|
Day 14
|
Serum prolactin ( PRL)
Time Frame: Day 14
|
Testing for affected hormone levels
|
Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Li Huafang, MD PhD, Shanghai Mental Health Center
- Principal Investigator: Li Guanjun, Shanghai Mental Health Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2022
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
March 1, 2024
Study Registration Dates
First Submitted
August 28, 2021
First Submitted That Met QC Criteria
December 30, 2021
First Posted (Actual)
January 14, 2022
Study Record Updates
Last Update Posted (Actual)
January 14, 2022
Last Update Submitted That Met QC Criteria
December 30, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BR-2020-1491-TPN672
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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