Recruiting PHASE1 Schizophrenia

Tests treatment safety and results for Schizophrenia

Official title Evaluating Safety, Tolerability and Pharmacokinetic of Multiple Ascending Doses of VV119

ClinicalTrials.gov ID: NCT06504290

What this study is testing

What is VV119 （in healthy adult subjects）?

VV119 （in healthy adult subjects） is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for schizophrenia.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: This study will consist of 2 parts: Part Ⅰ-in healthy adult subjects, Part Ⅱ-in adult patients with schizophrenia

Phase 1: an early, usually small safety study
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65. Healthy volunteers may be eligible.

You may be able to join if

Healthy adult people：
Males: aged 18 to 45 years old, Body weight no less than 50.0kg; females: Aged 18 to 60 years old, Body weight no less than 45.0kg, Body Mass Index...
Medically healthy, physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or...
Males' people who are willing to take effective contraceptive during the study and within 6 months after the study completed; females of...
people who are able to understand and follow study plans and instructions; people who have voluntarily decided to participate in this study and...

You likely can't join if

Healthy adult people：
With current or past medical history diseases or dysfunction that affect the clinical trial, evaluated by the investigator, including but not limited...
With current or previous mental disorders and brain dysfunction, or suicide risk according to the clinical judgment of the investigator, or a history...
With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may...
With a known history of allergy to investigating drug ingredients or similar drugs, a history of allergic diseases or allergic constitution.
Positive for hepatitis B virus surface antigen （HBsAg）, or syphilis antibody (Anti-TP), or hepatitis C antibody (anti-HCV), or human immunodeficiency...

See the full eligibility criteria

Who can join

Healthy adult people：
Males: aged 18 to 45 years old, Body weight no less than 50.0kg; females: Aged 18 to 60 years old, Body weight no less than 45.0kg, Body Mass Index of 19.0 to 26.0kg/m2.
Medically healthy, physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or abnormal without clinical significance.
Males' people who are willing to take effective contraceptive during the study and within 6 months after the study completed; females of non-child-bearing potential.
people who are able to understand and follow study plans and instructions; people who have voluntarily decided to participate in this study and signed the informed consent form. Adult patients with schizophrenia:
Aged 18 to 65 years old, Body Mass Index of 18.5 to 30kg/m2, males, Body weight no less than 50.0kg; females: Body weight no less than 45.0kg.
Males' people who are willing to take effective contraceptive during the study and within 6 months after the study completed; females of non-child-bearing potential.
Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 and MINI at least 1 year.
Subject is experiencing an acute exacerbation or relapse of psychotic symptoms.
PANSS total score at least 70 and CGI-S score of ≥4 at screening.
people who have a history of antipsychotics.
The people 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...

What rules you out

Healthy adult people：
With current or past medical history diseases or dysfunction that affect the clinical trial, evaluated by the investigator, including but not limited to central nervous system, cardiovascular system, respiratory system...
With current or previous mental disorders and brain dysfunction, or suicide risk according to the clinical judgment of the investigator, or a history of self-mutilation.
With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the people participating in the trial, such as history...
With a known history of allergy to investigating drug ingredients or similar drugs, a history of allergic diseases or allergic constitution.
Positive for hepatitis B virus surface antigen （HBsAg）, or syphilis antibody (Anti-TP), or hepatitis C antibody (anti-HCV), or human immunodeficiency virus antigen/antibody combined detection (HIV-Ag/Ab).
With a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial.
With a blood donation or blood loss ≥ 400mL within 3 months before screening, or a blood donation or blood loss ≥ 200mL within 1 month, or a history of blood product use within 3 months before screening.
Taking any prescription drugs, over-the-counter drugs, and any functional vitamins or herbal products within 2 weeks before screening.
Using any drugs that inhibit or induce hepatic drug metabolizing enzymes CYP3A4, CYP3A5, CYP2D6 (such as inducers - phenobarbital, rifampicin, carbamazepine, phenytoin sodium, glucocorticoids, etc.; inhibitors -...
Participating in any clinical trial and taking clinical trial drugs within 3 months before screening, or being participating in other clinical trials.
Smoke test positive or smoking more than 5 cigarettes per day or average intake of coffee or tea more than 5 cups per day (200 mL/cup) within 3 months before screening, or unable to stop users during the study.
With alcohol abuse within 1 year before screening, average weekly alcohol intake more than 14 standard units [1 unit = 360 mL beer (alcohol content 5%) or 45 mL spirits (alcohol content 40%) or 150 mL wine (alcohol...
With a history of drug abuse within 1 year before screening, or positive for urine drug screening.
With a family history of sudden cardiac death (sudden death age less than 40 years).
With a resting pulse \< 50 beats/min or ≥ 100 beats/min; resting systolic blood pressure \< 85 mmHg or ≥ 140 mmHg; resting diastolic blood pressure \< 50 mmHg or ≥ 90 mmHg; systolic blood pressure decreased by ≥ 20 mmHg...
Abnormal in 12-lead electrocardiogram (ECG), clinically significant judged by the investigator (e.g., QTcF\> 450 ms in men and \> 470 ms in women).
With the aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (Cr), urea (Urea), serum prolactin levels beyond the upper limit of normal (ULN)，Neutrophil count below the lower limit of normal...
Having special requirements for food, unable to observe a unified diet or having dysphagia.
Rejecting abide by the following conditions during the trial: smoking, alcohol or caffeine-containing beverages are prohibited, and strenuous exercise is avoided.
Directly related to this clinical trial.
Other people that the investigator considers inappropriate for this trial. Adult patients with schizophrenia:
Patients who meet the DSM-5 diagnostic criteria for other mental diseases.
Patients with refractory schizophrenia to be defined as patients with treatment-resistant schizophrenia who have not achieved clinical improvement after a full course of treatment with at least 2 antipsychotics in the...
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...
There are diseases or functional disorders that affect the clinical trial, including but not limited to neuropsychiatric, cardiovascular, urinary, digestive, respiratory, muscular, metabolic endocrine, hematology...
With any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the people participating in the trial, such as history...
With a history of epilepsy (except for febrile convulsion).
With a history of Malignant syndrome.
With a history of severe allergies.
Received electric shock treatment, and transcranial magnetic stimulation (rTMS) within 3 months before screening;
people are receiving or have recently received (within 5 half-lives, before baseline [Day -1]) oral antipsychotic medications, antidepressants or mood stabilizers.
CYP3A4 or CYP2D6 potent inhibitors, moderate inhibitors, potent inducers and moderate inducers used within 5 half-lives before enrollment.
Those who have physical examination abnormalities unrelated to schizophrenia at screening, which are judged by the investigator to have an impact on this trial.
With a resting pulse \< 50 beats/min or ≥ 100 beats/min; resting systolic blood pressure \< 85 mmHg or ≥ 140 mmHg; resting diastolic blood pressure \< 50 mmHg or ≥ 90 mmHg; systolic blood pressure decreased by ≥ 20 mmHg...
Abnormal in 12-lead electrocardiogram （ECG）, clinically significant judged by the investigator (e.g., QTcF\> 450ms in men and \> 470ms in women).
The laboratory examination during the screening period was abnormal, and the researcher determined that it was of obvious clinical significance, such as: glutamate aminotransferase (ALT) or aspartate aminotransferase...
With a history of drug abuse within 1 year before screening, or positive for urine drug screening.
With alcohol abuse within 1 year before screening, average weekly alcohol intake more than 14 standard units [1 unit = 360mL beer (alcohol content 5%) or 45mL spirits （alcohol content 40%） or 150mL wine （alcohol content...
Rejecting abides by the following conditions during the trial: smoking, alcohol or caffeine-containing beverages are prohibited, and strenuous exercise is avoided.
Positive for hepatitis B virus surface antigen （HBsAg）, or syphilis antibody (Anti-TP), or hepatitis C antibody (anti-HCV), or human immunodeficiency virus antigen/antibody combined detection (HIV-Ag/Ab).
With a blood donation or blood loss ≥ 400mL within 3 months before screening, or a blood donation or blood loss ≥ 200mL within 1 month.
Participation in another clinical study within 3 months before screening in which the subject received an experimental or investigational drug agent,or are participating in clinical trials.
Other people that the investigator considers inappropriate for this trial.

The study team makes the final eligibility decision.

Where it's taking place

Beijing, Beijing Municipality, China
Xi’an, Shanxi, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Beijing, Beijing Municipality, China; Xi’an, Shanxi, China. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.