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SchizophreniaPhase 1/2NCT06356389

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

A Phase 1/2 study testing JX11502MA in people with Schizophrenia, run by Zhejiang Jingxin Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Schizophrenia
What is being tested?
JX11502MA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
2 Mar 2022to 28 Jan 2023
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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • At the time of signing the informed consent form, 18 years old ≤ 55 years old, male and female are not limited;
  • 18.5kg/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.

Who cannot join

  • 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;
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  • 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);
  • Subjects who may be allergic to any component of this drug or its analogues;
  • HIV antibody, HBsAg, HCV antibody or syphilis serological test result is positive;
  • There is obvious history of blood loss, blood donation or blood loss ≥ 200mL within 3 months before screening;
  • Those who have been enrolled in other clinical trials or are participating in clinical trials within 3 months before screening;
  • Pregnant or lactating women;
  • The researcher thinks it is not suitable to participate in this test.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 201109

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of JX11502MA Capsules in Patients With Schizophrenia.

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

Read the detailed description

This study adopts a multi-center, randomized, double-blind, dose-increasing, parallel-control titration drug delivery study design.

Preset three dose groups (S1, S2, S3), low, medium and high, with target doses of 1.5mg, 3mg and 6mg respectively. Each dose group included 20 subjects (16 patients received the test drug and 4 patients received placebo). During the test, observe the safety and tolerance of the subjects, and collect PK blood samples.

Schizophrenic patients who met the inclusion criteria after screening and evaluation were randomly enrolled on the baseline day. On the first administration day, all dose groups took 1.5mg as the starting dose. Each subject should closely observe the tolerance and safety within 24 hours after the first administration. Only when the investigator evaluated it as tolerable, can the subsequent multiple administration be continued.

Conditions
Schizophrenia
Being tested
JX11502MA, Placebo
Keywords
Schizophrenia
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JX11502MADrug

    Oral capsule

  • PlaceboDrug

    Oral capsule

Study groups in NCT06356389
Study groupRoleWhat they receive
JX11502MAExperimentalJX11502MA 1.5 mg; JX11502MA 3 mg; JX11502MA 6 mg;
Receives: Drug: JX11502MA
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (TEAEs)

    The number and percentage of participants with TEAEs will be determined

    Measured: Day1 to Day 28

Secondary outcomes (12)

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

    The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For negative symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

    Measured: Day1 to Day 28

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

    The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For positive symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

    Measured: Day1 to Day 28

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

    The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For negative symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

    Measured: Day1 to Day 28

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

    The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.

    Measured: Day1 to Day 28

  5. Tmax

    Peak time

    Measured: Day1 to Day 28

  6. Css_min

    Steady-state trough concentration

    Measured: Day1 to Day 28

  7. Css_max

    Steady-state peak concentration

    Measured: Day1 to Day 28

  8. Css_av

    Mean steady-state blood drug concentration

    Measured: Day1 to Day 28

  9. AUC0-t,ss

    Area under the plasma concentration-time curve from the last dose to the last measurable concentration time point

    Measured: Day1 to Day 28

  10. AUC0-∞,ss

    Extrapolated area under the plasma concentration-time curve from the last dose to infinity

    Measured: Day1 to Day 28

  11. AUCtau,ss

    Area under the plasma concentration-time curve within one dosing interval at steady state

    Measured: Day1 to Day 28

  12. t1/2

    Elimination half-life

    Measured: Day1 to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start2 Mar 2022
  3. Primary completion27 Dec 2022
  4. Study completion28 Jan 2023

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06356389
Sponsor's protocol ID
JX11502MA-Ib-II
Status last verified
Apr 2024
First submitted
20 Feb 2023
Last updated
10 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JX11502MA in people with Schizophrenia, run by Zhejiang Jingxin 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 7 inclusion and 21 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: finished, as of the sponsor's last update on 10 Apr 2024. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of treatment-emergent adverse events (TEAEs) (time frame: Day1 to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06356389.

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 10 Apr 2024.

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