RecruitingPhase 1NCT06105151

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

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Food Effects of a Single Oral VV119 Capsule in Healthy Chinese Volunteers

Sponsor

Vigonvita Life Sciences

Enrollment

82 participants

Start Date

Oct 27, 2023

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing the safety, how the body processes, and the effects of food on a new investigational drug called VV119 in healthy Chinese volunteers. No disease treatment is involved — the study is just assessing safety and drug behavior. **You may be eligible if...** - You are a healthy male aged 18–45 (weight ≥ 50 kg) or a female aged 18–60 (weight ≥ 45 kg) who cannot become pregnant - Your body mass index (BMI) is 19.0–26.0 kg/m² - You have normal or near-normal results on physical exam, vital signs, blood tests, and heart tracing - You are willing to use contraception (if male) for 3 months after the study ends - You can understand the study instructions and give informed consent **You may NOT be eligible if...** - You have a history of serious illness affecting any major organ system (heart, brain, lungs, kidneys, liver, blood, etc.) - You have a history of mental health disorders or suicide risk - You have had gastrointestinal surgery (like stomach removal) or bowel conditions that affect drug absorption - You have known drug allergies relevant to the study drug - You smoke, drink heavily, or use recreational drugs - You have participated in another clinical trial recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVV119(SAD)

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;

DRUGVV119 Placebo(SAD)

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;

DRUGVV119(FE)

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；