SchizophreniaPhase 1TPN672NCT05192304
Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TPN672 Tablets Maleate in Patients With Schizophrenia
A Phase 1 study testing TPN-672 in people with Schizophrenia, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a Phase Ib clinical study of TPN672 maleate in patients 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?
- TPN-672
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 1 Mar 2024
- Phase
- Phase 1
- 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
LI Huafang, 86-21-34773107, lhlh_5@163.com
About this study
Official title: 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
Read the 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
- Conditions
- Schizophrenia
- Being tested
- TPN-672
- Keywords
- Phase Ib, CHINA
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPN-672Drug
Also called single dose of TPN-672 maleate tablet
single dose of TPN-672 maleate tablet
| Study group | Role | What they receive |
|---|---|---|
| 0.2mg single dose | Experimental | single dose of TPN-672 0.2mg, 2 subjects Receives: Drug: TPN-672 |
| 0.3mg single dose | Experimental | single dose of TPN-672 0.3mg, 12 subjects（9 for TPN-672, 3 for placebo） Receives: Drug: TPN-672 |
| 0.4mg single dose | Experimental | single dose of TPN-672 0.4mg, 12 subjects（9 for TPN-672, 3 for placebo） Receives: Drug: TPN-672 |
| 0.5mg single dose | Experimental | single dose of TPN-672 0.5mg, 12 subjects（9 for TPN-672, 3 for placebo） Receives: Drug: TPN-672 |
| 0.6mg single dose | Experimental | single dose of TPN-672 0.6mg, 12 subjects（9 for TPN-672, 3 for placebo） Receives: Drug: TPN-672 |
| 0.7mg single dose | Experimental | single dose of TPN-672 0.7mg, 12 subjects（9 for TPN-672, 3 for placebo） Receives: Drug: TPN-672 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence of Adverse Events
Measured: follow-up visit from the beginning of the dose to the day 14 after the last dose
Blood pressure
Safety indicator,Blood pressure is recorded in millimeters of mercury
Measured: Day 14
Respiration
Safety indicator，the unit of recording is the number of breaths per minute.
Measured: Day 14
Heart rate
Safety indicator，the unit of heart rate is the number of heartbeats per minute.
Measured: Day 14
Temperature
Safety indicator,Body temperature is recorded in degrees Celsius
Measured: Day 14
Secondary outcomes (11)
Maximum plasma concentration (Cmax)
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).
Measured: 240 hours
Time to maximum plasma concentration (Tmax)
Biological sample including blood for PK will be collected at the same time point.
Measured: 240 hours
Area under the curve (AUC)
Biological sample including blood for PK will be collected at the same time point.
Measured: 240 hours
steady state minimal concentration（Css_min）
Biological sample including blood for PK will be collected at the same time point
Measured: 240hours
Elimination half-life (t1/2)
Biological sample including blood for PK will be collected at the same time point.
Measured: 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
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.
Measured: Follow-up visit on the day 14 after the last dose
Clinical Global Impression sions scale
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.
Measured: Follow-up visit on the day 14 after the last dose
Calgary Depression Scale for Schizophrenia
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.
Measured: Follow-up visit on the day 14 after the last dose
Blood coagulation function
Safety indicators, including PT,APTT
Measured: Day 14
12-lead ECG
Safety indicators, including QTc
Measured: Day 14
Serum prolactin ( PRL)
Testing for affected hormone levels
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Mental Health Center
- Responsible party
- Sponsor
- Investigators
- Li Huafang, MD PhD, Principal investigator, Shanghai Mental Health CenterLi Guanjun, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192304
- Sponsor's protocol ID
- BR-2020-1491-TPN672
- Acronym
- TPN672
- Status last verified
- Oct 2021
- First submitted
- 28 Aug 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05192304
- Acronym / sponsor ID
- TPN672 / BR-2020-1491-TPN672
- Conditions
- Schizophrenia
- Keywords
- Phase Ib, CHINA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Mental Health Center
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 14 Jan 2022 (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.
This is a Phase Ib clinical study of TPN672 maleate in patients with schizophrenia
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0.2mg single dose | Experimental | Drug: TPN-672single dose of TPN-672 0.2mg, 2 subjects |
| 0.3mg single dose | Experimental | Drug: TPN-672single dose of TPN-672 0.3mg, 12 subjects（9 for TPN-672, 3 for placebo） |
| 0.4mg single dose | Experimental | Drug: TPN-672single dose of TPN-672 0.4mg, 12 subjects（9 for TPN-672, 3 for placebo） |
| 0.5mg single dose | Experimental | Drug: TPN-672single dose of TPN-672 0.5mg, 12 subjects（9 for TPN-672, 3 for placebo） |
| 0.6mg single dose | Experimental | Drug: TPN-672single dose of TPN-672 0.6mg, 12 subjects（9 for TPN-672, 3 for placebo） |
| 0.7mg single dose | Experimental | Drug: TPN-672single dose of TPN-672 0.7mg, 12 subjects（9 for TPN-672, 3 for placebo） |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
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 |
|---|---|---|
| TPN-672Also: single dose of TPN-672 maleate tabletsingle dose of TPN-672 maleate tablet | Drug | 0.2mg single dose, 0.3mg single dose, 0.4mg single dose, 0.5mg single dose, 0.6mg single dose, 0.7mg single dose |
Primary outcome
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
Blood pressure
Time frame: Day 14
Safety indicator,Blood pressure is recorded in millimeters of mercury
Respiration
Time frame: Day 14
Safety indicator，the unit of recording is the number of breaths per minute.
Heart rate
Time frame: Day 14
Safety indicator，the unit of heart rate is the number of heartbeats per minute.
Temperature
Time frame: Day 14
Safety indicator,Body temperature is recorded in degrees Celsius
11 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: 240 hours
Time to maximum plasma concentration (Tmax)
Time frame: 240 hours
Area under the curve (AUC)
Time frame: 240 hours
steady state minimal concentration（Css_min）
Time frame: 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.
Positive and Negative Syndrome Scale
Time frame: Follow-up visit on the day 14 after the last dose
Clinical Global Impression sions scale
Time frame: 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
Blood coagulation function
Time frame: Day 14
12-lead ECG
Time frame: Day 14
Serum prolactin ( PRL)
Time frame: Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- 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.
Li Huafang, MD PhD principal investigator
Shanghai Mental Health Center
Li Guanjun principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TPN-672 in people with Schizophrenia, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 1 site in China.
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 8 inclusion and 22 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 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Contact Zhao Binjiang (86-518-85521987, 13466570402@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: follow-up visit from the beginning of the dose to the day 14 after the last dose). The study lists 5 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 14 Jan 2022.