Recruiting
PHASE1
INTERVENTIONAL
NCT06504290
Evaluating Safety, Tolerability and Pharmacokinetic of Multiple Ascending Doses of VV119
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This study will consist of 2 parts: Part Ⅰ-in healthy adult subjects, Part Ⅱ-in adult patients with schizophrenia
Detailed Description
Part Ⅰ was designed as single-center, randomized, double-blind, placebo-controlled, dose-escalation trial to assess the safety, tolerability, pharmacokinetics （PK） of multiple doses of VV119 in Chinese healthy adult subjects. Part Ⅱ was designed as multicenter, randomized, double-blind, placebo-controlled, dose-escalation trial to assess the safety, tolerability, pharmacokinetics （PK） and efficacy of multiple doses of VV119 in adult patients with schizophrenia.
Interventions
Name:
VV119 Placebo （in healthy adult subjects）
Type:
DRUG
Description:
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.
Name:
VV119 （in healthy adult subjects）
Type:
DRUG
Description:
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.
Name:
VV119(in adult patients with schizophrenia)
Type:
DRUG
Description:
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.
Name:
VV119 Placebo （in adult patients with schizophrenia）
Type:
DRUG
Description:
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.
Primary Outcomes
Measure:
Incidence of Treatment-Emergent Adverse Events
TimeFrame:
Baseline to 15 days after the last administration
Description:
Incidence of Treatment-Emergent Adverse Events
Trial Information
NCT ID
NCT06504290
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Vigonvita Life Sciences
Last Updated
December 15, 2025