RecruitingPhase 1NCT06504290

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

A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VV119 Capsules With Multiple Ascending Doses in Chinese Healthy Adult Subjects and Patients With Schizophrenia

Sponsor

Vigonvita Life Sciences

Enrollment

40 participants

Start Date

Jul 16, 2024

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug called VV119 to see how the body processes it and whether it is safe. It is being tested first in healthy volunteers at increasing doses, and then in patients diagnosed with schizophrenia. **You may be eligible if (healthy volunteers)...** - You are 18–45 years old (males) or 18–60 years old (females) - You are in good health with no significant medical conditions - You are willing to use contraception during and for 6 months after the study **You may be eligible if (patients with schizophrenia)...** - You are 18–65 years old with a confirmed diagnosis of schizophrenia - You meet specific health and weight requirements - You are willing to use contraception **You may NOT be eligible if...** - You have any serious or uncontrolled medical conditions - You are pregnant or capable of becoming pregnant - You have participated in another drug study recently - You have a history of drug or alcohol dependence 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 Placebo （in healthy adult subjects）

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.

DRUGVV119 （in healthy adult subjects）

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.

DRUGVV119(in adult patients with schizophrenia)

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.

DRUGVV119 Placebo （in adult patients with schizophrenia）

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.