Could a new pill for schizophrenia pass its first human test?
NCT ID NCT06105151
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This early-stage trial evaluates an experimental oral drug called VV119, which is being developed for schizophrenia. The study enrolls healthy volunteers to receive a single dose of VV119 or a placebo, with some participants taking it with food to see if meals affect how the drug is absorbed. Researchers will monitor safety, side effects, and how the drug moves through the body. This is a first step to determine if VV119 is safe enough to study further in people with schizophrenia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VV119, an experimental oral drug being tested for schizophrenia
- What this could lead to
- If successful, this early trial could pave the way for a new oral medication option for schizophrenia, potentially offering better tolerability or convenience.
- What could go wrong
- This is a very early phase 1 study in healthy people, not patients. It primarily checks safety and how the drug behaves, so it may not lead to an effective treatment, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 82 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males:aged 18 to 45 years old, males ,Body weight no less than 50.0 kg ; females :Aged 18 to 60 years old ,Body weight no less than 45.0 kg ,Body Mass Index of 19.0 to 26.0kg/m2, 2. Medically healthy, Physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or abnormal without clinical significance, 3. Males subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed; females not of child-bearing potential, 4. 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. Exclusion Criteria: Unless otherwise noted, the exclusion criteria were consistent for subjects in the SAD study and FE study. The following subjects will be excluded: 1. 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; 2. 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; 3. 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. 4. With a known history of allergy to investigating drug ingredients or similar drugs, a history of allergic diseases or allergic constitution; 5. 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); 6. 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; 7. With a blood donation or blood loss ≥ 400 mL within 3 months before screening, or a blood donation or blood loss ≥ 200 mL within 1 month, or a history of blood product use within 3 months before screening; 8. Taking any prescription drugs, over-the-counter drugs, and any functional vitamins or herbal products within 2 weeks before screening; 9. 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; 10. Participating in any clinical trial and taking clinical trial drugs within 3 months before screening, or being participating in other clinical trials; 11. 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; 12. 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; 13. With a history of drug abuse within 1 year before screening, or positive for urine drug screening; 14. With a family history of sudden cardiac death (sudden death age less than 40 years); 15. 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; 16. Abnormal in 12-lead electrocardiogram (ECG), clinically significant judged by the investigator (e.g., QTcF\> 450 ms in men and \> 470 ms in women); 17. With the aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (Cr), urea (Urea), serum prolactin levels beyond the upper limit of normal (ULN); 18. Having special requirements for food, unable to observe a unified diet or having dysphagia; 19. Rejecting abide by the following conditions during the trial: smoking, alcohol or caffeine-containing beverages are prohibited, and strenuous exercise is avoided; 20. Directly related to this clinical trial; 21. Other subjects that the investigator considers inappropriate for this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality, 100088, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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