Actively Recruiting
Evaluating Safety, Tolerability and Pharmacokinetic of Multiple Ascending Doses of VV119
Led by Vigonvita Life Sciences · Updated on 2026-04-28
40
Participants Needed
4
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will consist of 2 parts: Part Ⅰ-in healthy adult subjects, Part Ⅱ-in adult patients with schizophrenia
CONDITIONS
Official Title
Evaluating Safety, Tolerability and Pharmacokinetic of Multiple Ascending Doses of VV119
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male adults aged 18 to 45 years with body weight at least 50.0 kg
- Healthy female adults aged 18 to 60 years with body weight at least 45.0 kg and BMI between 19.0 and 26.0 kg/m2
- Medically healthy with normal or clinically insignificant abnormal exam and lab results
- Males willing to use effective contraception during and for 6 months after the study; females of non-child-bearing potential
- Able to understand study plans, follow instructions, and provide informed consent
- Adult patients with schizophrenia aged 18 to 65 years with BMI between 18.5 and 30 kg/m2
- Patients with schizophrenia: males with body weight at least 50.0 kg; females at least 45.0 kg
- Diagnosis of schizophrenia established at least 1 year prior by DSM-5 and MINI
- Experiencing acute exacerbation or relapse of psychotic symptoms
- PANSS total score of at least 70 and CGI-S score of 4 or higher at screening
- History of antipsychotic treatment
- Patients and guardians understand study purpose, consent, and agree to complete the trial
You will not qualify if you...
- History or current diseases affecting trial participation including major organ systems or malignancy
- Mental disorders other than schizophrenia, brain dysfunction, suicide risk, or history of self-harm
- Surgical conditions affecting drug absorption or posing risk (e.g., gastrointestinal surgery, urinary obstruction)
- Known allergy to study drug components or similar drugs
- Positive for hepatitis B surface antigen, syphilis antibody, hepatitis C antibody, or HIV
- Recent surgery within 3 months before screening or planned surgery during trial
- Recent blood donation or loss exceeding specified volumes
- Use of prescription, over-the-counter drugs, vitamins, or herbal products within 2 weeks before screening
- Use of drugs affecting hepatic enzymes CYP3A4, CYP3A5, CYP2D6 within 4 weeks before screening
- Participation in other clinical trials or use of trial drugs within 3 months before screening
- Smoking more than 5 cigarettes daily or high caffeine intake within 3 months before screening
- Alcohol abuse or positive alcohol breath test within 1 year before screening
- Drug abuse or positive urine drug screen within 1 year before screening
- Family history of sudden cardiac death before age 40
- Abnormal vital signs or ECG judged clinically significant
- Abnormal liver, kidney, blood, or prolactin lab values beyond normal limits
- Special dietary needs or inability to follow unified diet during trial
- Refusal to avoid smoking, alcohol, caffeine, or strenuous exercise during trial
- Other conditions or investigator judgment deeming unsuitability for trial
- For schizophrenia patients: diagnosis of other mental illnesses, treatment-resistant schizophrenia
- Suicidal ideation or tendencies per Columbia Suicide Scale or investigator evaluation
- History of epilepsy (except febrile convulsions), malignant syndrome, or severe allergies
- Recent electroconvulsive or transcranial magnetic stimulation within 3 months
- Recent use of antipsychotics, antidepressants, mood stabilizers, or certain enzyme modulators
- Physical abnormalities unrelated to schizophrenia impacting trial participation
- Other investigator-determined reasons for exclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
2
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
3
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
4
Xi'an Mental Health Center
Xi’an, Shanxi, China
Actively Recruiting
Research Team
H
Huaqing Duan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here