RecruitingPhase 1

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

China40 participantsStarted 2024-07-16

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: Baseline to 15 days after the last administration

Trial details

NCT IDNCT06504290

SponsorVigonvita Life Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-01

Contact for this trial

Huaqing Duan

+8618061926005 huaqing.duan@vigonvita.cn

View on ClinicalTrials.gov More Schizophrenia trials