A Clinical Trial to Evaluate Safety, Tolerance and Pharmacokinetics of JX11502MA Capsule in Patients With Schizophrenia.

NCT06356389 | Completed Phase 1

• 1 other identifier: JX11502MA-Ib-II
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, randomized, double-blind, placebo-controlled, dose-increasing phase Ib/II clinical trial to evaluate the safety, tolerance and pharmacokinetic characteristics of JX11502MA capsules administered multiple times in patients with schizophrenia

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  The number and percentage of participants with TEAEs will be determined

  Day1 to Day 28

Secondary Outcomes (12)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 28

  Day1 to Day 28

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Day 28

  Day1 to Day 28

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Day 28

  Day1 to Day 28

• Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28

  Day1 to Day 28

• Tmax

  Day1 to Day 28

Study Arms (2)

JX11502MA

EXPERIMENTAL

JX11502MA 1.5 mg; JX11502MA 3 mg; JX11502MA 6 mg;

Drug: JX11502MA

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

JX11502MA DRUG

Oral capsule

JX11502MA

Placebo DRUG

Oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• At the time of signing the informed consent form, 18 years old ≤ 55 years old, male and female are not limited;
• kg/m2 ≤ body mass index (BMI) ≤ 30kg/m2, and male weight ≥ 50kg, female weight ≥ 45kg;
• Subjects were diagnosed as schizophrenia according to DSM-5 diagnostic criteria;
• Subjects are currently taking second-generation antipsychotics (≤ 2 kinds, except for clozapine and long-acting preparations), the dose does not exceed the maximum dose specified in the instructions, and the dose and frequency of administration are basically stable in the past 2 weeks; Or currently useless drugs but taking second-generation antipsychotic drugs in the past ≥ 2 weeks;
• The total score of the PANSS scale in the screening period is less than 90 points, of which the following items are scored ≤ 4 points (such as P4, P6, P7, G2, G4, G8, G14);
• Female and male subjects of childbearing age and their spouses need to be able to effectively contraception (medically approved contraceptives, such as intrauterine devices, contraceptives or condoms) during the study medication period and within 6 months after the end of medication;
• The subjects and their guardians fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent form, and are willing to complete the whole trial process according to the trial requirements.

You may not qualify if:

• Patients who meet the DSM-5 diagnostic criteria for other mental diseases;
• Use long-acting antipsychotic drugs within 6 months before the first administration;
• He received electric shock treatment and transcranial magnetic stimulation (rTMS) within 3 months before screening;
• The answer to question 4 or 5 of the Columbia Suicide Scale (C-SSRS) suicide ideation in the screening period is "yes", or the person who has obvious suicide tendency at present or in the past 12 months, or the researcher believes that there is a risk of suicide and violence based on the clinical evaluation of the researcher;
• Those with abnormal physical examination or vital signs in screening period and significant clinical significance;
• The laboratory examination during the screening period was abnormal, and the researcher determined that it was of obvious clinical significance, such as: liver: glutamate aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of the normal value; Kidney: creatinine (Cr)\>upper limit of normal value;
• The increase of prolactin in the screening period is judged by the researcher to have obvious clinical significance (such as amenorrhea, breast development and other clinical symptoms);
• During the screening period, the subjects' systolic blood pressure was\<90mmHg or\>140mmHg, and their diastolic blood pressure was\<60mmHg or\>90mmHg;
• Diabetes patients with poor control (fasting blood glucose ≥ 10mmol/L), or are using insulin to treat diabetes, or initially diagnosed as type 2 diabetes at screening;
• Those with QTc interval\>450ms (male) or 470ms (female) in the screening period, or with family history of long QT interval syndrome, or with cardiac insufficiency, serious arrhythmia or ischemic heart disease and requiring drug treatment, have congenital heart disease, serious organic heart disease or a history of this disease;
• Those with epilepsy and other convulsive diseases (except for febrile convulsion);
• Those with serious or unstable cardiovascular, respiratory, liver, kidney, blood, endocrine, nervous system or other system diseases;
• Smokers who smoke more than 10 cigarettes or the same amount of cigarettes per day within 3 months before screening;
• Those who drink alcohol within 6 months before screening and have an average weekly alcohol intake of more than 14 units (1 unit=285 mL of beer or 25 mL of spirits or 150 mL of wine) or who have positive alcohol breath test;
• Those who have a history of drug and drug abuse within one year before screening, or who are positive for urine drug screening (excluding benzodiazepine);

Sponsors & Collaborators

• Zhejiang Jingxin Pharmaceutical Co., Ltd.: lead
• Shanghai Mental Health Center: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 201109, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: April 10, 2024
• Study Start: March 2, 2022
• Primary Completion: December 27, 2022
• Study Completion: January 28, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)