Evaluating Safety, Tolerability and Pharmacokinetic of Multiple Ascending Doses of VV119
NCT Number: NCT06504290
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Schizophrenia
Interventions: DRUG: VV119 Placebo （in healthy adult subjects）|DRUG: VV119 （in healthy adult subjects）|DRUG: VV119(in adult patients with schizophrenia)|DRUG: VV119 Placebo （in adult patients with schizophrenia）
Sponsor: Vigonvita Life Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-16
Completion Date: 2025-07-01
Locations: Beijing Anding Hospital of Capital Medical University, Beijing, Beijing, China|Beijing Huilongguan Hospital, Beijing, Beijing, China|Xi'an Mental Health Center, Xi'an, Shanxi, China

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

Primary Outcome Measures: Incidence of Treatment-Emergent Adverse Events, Incidence of Treatment-Emergent Adverse Events, Baseline to 15 days after the last administration
Secondary Outcome Measures: Cmax, maximum observed plasma concentration of VV119 and the main metabolites, Baseline to 360 hours after the last administration|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, Baseline to 360 hours after the last administration|AUC0-∞, area under the plasma concentration time curve from time zero to infinity of VV119 and the main metabolites, Baseline to 360 hours after the last administration|Tmax, time at which Cmax occurs of VV119 and the main metabolites of VV119 and the main metabolites, Baseline to 360 hours after the last administration|t1/2, half-life of elimination of VV119 and the main metabolites, Baseline to 360 hours after the last administration|Apparent Clearance Rate（CL/F）, apparent clearance of VV119 and the main metabolites, Baseline to 360 hours after the last administration|Vd/F, apparent volume of distribution during the terminal phase of VV119 and the main metabolites, Baseline to 360 hours after the last administration|Ke, elimination rate constant of VV119 and the main metabolites, Baseline to 360 hours after the last administration|AUC0-24h, area under the plasma concentration time curve from time zero to 24h of VV119 and the main metabolites, Baseline to 360 hours after the last administration|mean Resident Time, mean Resident Time from time zero to infinity/the last of VV119 and the main metabolites, Baseline to 360 hours after the last administration|Positive and Negative Syndrome Scale （PANSS）, Change from Baseline in Positive and Negative Syndrome Scale in part Ⅱ。 The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales,7negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms., Day-1,Day14,Day28 and Day42|PANSS Positive subscale score, Change from Baseline in PANSS Positive subscale score in part Ⅱ PANSS-Positive: Assessment of positive symptoms. Minimum value:7, maximum value:49, the higher scores mean a worse outcome., Day-1, Day14, Day28 and Day42|PANSS Negative subscale score, Change from Baseline in PANSS Negative subscale score in part Ⅱ。 PANSS-negative: Assessment of negative symptoms. Minimum value:7, maximum value:49, the higher scores mean a worse outcome., Day-1, Day14, Day28 and Day42|Treatment response rate, Positive and Negative Syndrome Scale （PANSS） Response rate, Defined as a 50% or Greater Improvement from Baseline in PANSS Total Score in part Ⅱ, Day-1,Day14, Day28 and Day42|Clinical Global Impression-Severity (CGI-S), Change from Baseline in Clinical Global Impression-Severity in part Ⅱ。 The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness., Day-14, Day28 and Day42|Rac, Accumulation Ratio of VV119, Baseline to 360 hours after the last administration