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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT06504290

Run by

Vigonvita Life Sciences

People needed

40

Starts

2024-07-16

Expected to finish

2026-07-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult subjects：
• 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' subjects who are willing to take effective contraceptive during the study and within 6 months after the study completed; females of non-child-bearing potential.
• Subjects who are able to understand and follow study plans and instructions; Subjects 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' subjects 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.
• Subjects who have a history of antipsychotics.
• 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…

• Healthy adult subjects：
• 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, digestive system, urinary system, endocrine system, blood system, ophthalmology and other diseases, history of malignant tumor or other diseases that are not suitable for participating in the clinical trial.
• 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 subjects participating in the trial, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcers, history of gastrointestinal bleeding, etc.
• 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 - ketoconazole, itraconazole, cimetidine, clarithromycin, verapamil, erythromycin, etc.) within 4 weeks (or 5 half-lives, whichever is longer) before screening.
• 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 content 12%)] or positive for alcohol breath test.
• 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 and/or diastolic blood pressure decreased by ≥ 10 mmHg and/or accompanied by clinical symptoms within 3 minutes of standing.
• 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 (LLN).
• 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 subjects 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 past 5 years.

Where it is running

• Beijing Anding Hospital of Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Beijing Anding Hospital of Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Beijing Huilongguan Hospital — Beijing, Beijing Municipality, China (enrolling)
• Xi'an Mental Health Center — Xi’an, Shanxi, China (enrolling)

Full record on ClinicalTrials.gov

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