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

NCT06504290 | Recruiting Phase 1

• 1 other identifier: VV119-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events

  Baseline to 15 days after the last administration

Secondary Outcomes (16)

• Cmax

  Baseline to 360 hours after the last administration

• area under the plasma concentration time curve from time zero to the last (AUC0-t)

  Baseline to 360 hours after the last administration

• AUC0-∞

  Baseline to 360 hours after the last administration

• Tmax

  Baseline to 360 hours after the last administration

• t1/2

  Baseline to 360 hours after the last administration

Study Arms (2)

Part Ⅰ- in healthy adult subjects

EXPERIMENTAL

Drug: VV119 Placebo （in healthy adult subjects）; Drug: VV119 （in healthy adult subjects）

Part Ⅱ-in adult patients with schizophrenia

EXPERIMENTAL

Drug: VV119(in adult patients with schizophrenia); Drug: VV119 Placebo （in adult patients with schizophrenia）

Interventions

VV119(in adult patients with schizophrenia) DRUG

VV119 2 mg Group:6 subjects will receive 2 0.5mgVV119 capsules on the first four days, then take 1 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the fifth day to the 28th day， orally once daily, VV119 4 mg Group:6 subjects will receive 2 0.5mgVV119 capsules on the first four days, take 1 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the fifth day to the seventh day , then 2 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the eighth day to the 28th day ,orally once daily, VV119 6 mg Group:6 subjects will receive 2 0.5mgVV119 capsules on the first three days,take 1 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the forth day to the fifth day , take 2 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the sixth day to the seventh day , then 3 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the eighth day to the 28th day ,orally once daily.

Part Ⅱ-in adult patients with schizophrenia

VV119 Placebo （in healthy adult subjects） DRUG

VV119 0.5 mg Group:2 subjects will receive VV119 Placebo 0.5 mg, orally once daily for 14 days. VV119 1 mg Group:2 subjects will receive VV119 Placebo 1 mg, orally once daily for 14 days.

Part Ⅰ- in healthy adult subjects

VV119 （in healthy adult subjects） DRUG

VV119 0.5 mg Group:6 subjects will receive VV119 0.5 mg, orally once daily for 14 days. VV119 1 mg Group:6 subjects will receive VV119 1 mg, orally once daily for 14 days.

Part Ⅰ- in healthy adult subjects

VV119 Placebo （in adult patients with schizophrenia） DRUG

VV119 2 mg Group:2 subjects will receive 1 0.5mgVV119 capsules and 1 0.5mg VV119 Placebo on the first four days, then take 1 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the fifth day to the 28th day， orally once daily, VV119 4 mg Group:2 subjects will receive 1 0.5mgVV119 capsules and 1 0.5mg VV119 Placebo on the first four days, take 1 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the fifth day to the seventh day , then 2 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the eighth day to the 28th day ,orally once daily, VV119 6 mg Group:2 subjects will receive 1 0.5mgVV119 capsules and 1 0.5mg VV119 Placebo on the first three days, take 1 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the forth day to the fifth day ,take 2 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the sixth day to the seventh day, then 3 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the eighth day to the 28th day ,orally once daily.

Part Ⅱ-in adult patients with schizophrenia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (4)

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Beijing Huilongguan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Xi'an Mental Health Center

Xi’an, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Gang Wang

  Beijing Anding Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaqing Duan

CONTACT

+8618061926005; huaqing.duan@vigonvita.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 16, 2024
• Study Start: July 16, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)