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Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TPN672 Tablets Maleate in Patients With Schizophrenia | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TPN672 Tablets Maleate in Patients With Schizophrenia

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

NCT05192304•Jiangsu Kanion Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 years old ≤ age ≤ 65 years old at the time of signing the informed consent form, male or female.
•2. 18.5kg/m2 ≤ body mass index (BMI) ≤ 30kg/m2, and weight ≥ 50kg for men and ≥ 45kg for women.
•3. 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.
•4. 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.
•5. Screening period PANSS scale total score \<70, PANSS scale individual score of positive symptom items ≤3, CGI-S score ≤4.
•6. 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.
•7. 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.
•8. 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

•1. Subjects met DSM-5 criteria for other psychiatric disorders.
•2. Subjects were administered strong inducers/strong inhibitors of CYP2D6, CYP3A4, CYP3A5, CYP2C9 for 5 half-lives prior to the first dose.
•3. Subjects were on long-acting antipsychotics for 6 months prior to their first dose.
•4. Received electroconvulsive therapy, transcranial magnetic stimulation (rTMS) within 1 month prior to screening
•5. 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.
•6. Those with abnormal physical examination or vital signs during the screening period that are clinically significant.
•7. 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.
•8. Prolactin ≥ 5 times the upper limit of normal during the screening period.
•9. Screening subjects with systolic blood pressure \<90 mmHg or \>140 mmHg and diastolic blood pressure \< 60mmHg or \>90mmHg.
•10. 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.
+12 more criteria

Locations (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

February 1, 2022

Primary Completion Date

March 1, 2023

Completion Date

March 1, 2024

Last Updated

January 14, 2022

Enrollment

ESTIMATED participants

Conditions

Schizophrenia

Interventions

TPN-672

DRUG

Contacts

Zhao Binjiang

CONTACT

86-518-85521987 13466570402@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TPN672 Tablets Maleate in Patients With Schizophrenia

Inclusion Criteria

Exclusion Criteria

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