Study of the Safety, Tolerability, Pharmacokinetics and Food Effects of VV119 Capsules in Chinese Healthy Volunteers

NCT06105151 | Recruiting Phase 1

• 1 other identifier: VV119-01
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This study will consist of 2 parts: Part Ⅰ - Single Ascending Dose (SAD) study, Part Ⅱ - Food Effect (FE) study

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (26)

• Incidence of Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events

  23 days after treatment in part Ⅰ;

• Incidence of Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events

  56 days after treatment in part Ⅱ;

• Cmax

  maximum observed plasma concentration of VV119 and the main metabolites

  360 hours after dosing in part Ⅰ;

• Cmax

  maximum observed plasma concentration of the main metabolites VV119-M2

  480 hours after dosing in part Ⅱ;

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

  area under the plasma concentration time curve from time zero to the last of VV119 and the main metabolites

  360 hours after dosing in part Ⅰ;

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

  area under the plasma concentration time curve from time zero to the last of the main metabolites VV119-M2

  480 hours after dosing in part Ⅱ;

• AUC0-∞

  area under the plasma concentration time curve from time zero to infinity of VV119 and the main metabolites

  360 hours after dosing in part Ⅰ;

• AUC0-∞

  area under the plasma concentration time curve from time zero to infinity of the main metabolites VV119-M2

  480 hours after dosing in part Ⅱ;

• Tmax

  time at which Cmax occurs of VV119 and the main metabolites of VV119 and the main metabolites

  360 hours after dosing in part Ⅰ;

• Tmax

  time at which Cmax occurs of VV119 and the main metabolites of the main metabolites VV119-M2

  480 hours after dosing in part Ⅱ;

• t1/2

  half life of elimination of VV119 and the main metabolites

  360 hours after dosing in part Ⅰ;

• t1/2

  half life of elimination of the main metabolites VV119-M2

  480 hours after dosing in part Ⅱ;

• Apparent Clearance Rate（CL/F）

  apparent clearance of VV119 and the main metabolites

  360 hours after dosing in part Ⅰ;

• Apparent Clearance Rate（CL/F）

  apparent clearance of the main metabolites VV119-M2

  480 hours after dosing in part Ⅱ;

• Vd/F

  apparent volume of distribution during the terminal phase of VV119 and the main metabolites

  360 hours after dosing in part Ⅰ;

• Vd/F

  apparent volume of distribution during the terminal phase of the main metabolites VV119-M2

  480 hours after dosing in part Ⅱ;

• Ke

  elimination rate constant of VV119 and the main metabolites

  360 hours after dosing in part Ⅰ;

• Ke

  elimination rate constant of the main metabolites VV119-M2

  480 hours after dosing in part Ⅱ;

• mean Resident Time from time zero to the last（MRT0-t）

  mean Resident Time from time zero to the last of VV119 of VV119 and the main metabolites

  360 hours after dosing in part Ⅰ;

• mean Resident Time from time zero to the last（MRT0-t）

  mean Resident Time from time zero to the last of the main metabolites VV119-M2

  480 hours after dosing in part Ⅱ;

• mean Resident Time from time zero to infinity（MRT0-∞)

  mean Resident Time from time zero to infinity of VV119 and the main metabolites

  360 hours after dosing in part Ⅰ;

• mean Resident Time from time zero to infinity（MRT0-∞)

  mean Resident Time from time zero to infinity of the main metabolites VV119-M2

  480 hours after dosing in part Ⅱ;

• AUC_%Extra

  area under plasma Concentration (AUC) extrapolated of VV119 and the main metabolites

  360 hours after dosing in part Ⅰ;

• AUC_%Extra

  area under plasma Concentration (AUC) extrapolated of the main metabolites VV119-M2

  480 hours after dosing in part Ⅱ;

• BP

  Blood Plasma Ratio of the main metabolites VV119-M2

  360 hours after dosing in part Ⅰ;

• BP

  Blood Plasma Ratio of VV119 and the main metabolites

  480 hours after dosing in part Ⅱ;

Secondary Outcomes (1)

• Metabolite Identification

  360 hours after dosing

Study Arms (3)

Part Ⅰ - Single Ascending Dose (SAD) study: Experimental

EXPERIMENTAL

Subjects will receive VV119 orally for single dose.

Drug: VV119(SAD)

Part Ⅰ - Single Ascending Dose (SAD) study: Placebo

EXPERIMENTAL

Subjects will receive VV119 placebo orally for single dose.

Drug: VV119 Placebo(SAD)

Part Ⅱ - Food Effect (FE) study: Experimental

EXPERIMENTAL

Subjects will receive VV119 orally for single dose.

Drug: VV119(FE)

Interventions

VV119(SAD) DRUG

VV119 0.2 mg Group: 2 subjects will receive VV119 0.2 mg, orally; VV119 0.5 mg Group: 6 subjects will receive VV119 0.5 mg, orally; VV119 1 mg Group: 6 subjects will receive VV119 1 mg, orally; VV119 2 mg Group: 6 subjects will receive VV119 2 mg, orally; VV119 3 mg Group:6 subjects will receive VV119 3 mg, orally; VV119 4.5 mg Group:6 subjects will receive VV119 4.5 mg, orally; VV119 6 mg Group:6 subjects will receive VV119 6 mg, orally; VV119 8 mg Group:6 subjects will receive VV119 8 mg, orally; VV119 10 mg Group:6 subjects will receive VV119 10 mg, orally;

Part Ⅰ - Single Ascending Dose (SAD) study: Experimental

VV119 Placebo(SAD) DRUG

VV119 0.5 mg Group: 2 subjects will receive VV119 Placebo 0.5 mg, orally; VV119 1 mg Group: 2 subjects will receive VV119 Placebo 1 mg, orally; VV119 2 mg Group: 2 subjects will receive VV119 Placebo 2 mg, orally; VV119 3 mg Group:2 subjects will receive VV119 Placebo 3 mg, orally; VV119 4.5 mg Group:2 subjects will receive VV119 Placebo 4.5 mg, orally; VV119 6 mg Group:2 subjects will receive VV119 Placebo 6 mg, orally; VV119 8 mg Group:2 subjects will receive VV119 Placebo 8 mg, orally; VV119 10 mg Group:2 subjects will receive VV119 Placebo 10 mg, orally;

Part Ⅰ - Single Ascending Dose (SAD) study: Placebo

VV119(FE) DRUG

A：2 mg VV119, following an overnight fast of at least 10 hours for Period 1; 2mg VV119, administered 30 minutes after the start of a high-fat meal for Period 2; B: 2mg VV119, administered 30 minutes after the start of a high-fat meal for Period 1;2mg VV119, following an overnight fast of at least 10 hours for Period 2；

Part Ⅱ - Food Effect (FE) study: Experimental

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,
• 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 3 months after the study completed; females not of 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.

You may not qualify if:

• 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 ≥ 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;
• 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;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, 100088, 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: October 17, 2023
• First Posted: October 27, 2023
• Study Start: October 27, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)