Evaluating Safety, Tolerability and Pharmacokinetic of Multiple Ascending Doses of VV119
ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVigonvita Life Sciences
About this trial
This study will consist of 2 parts: Part Ⅰ-in healthy adult subjects, Part Ⅱ-in adult patients with schizophrenia
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males: aged 18 to 45 years old, Body weight no less than 50.0kg; females: Aged 18 to 60 years old, Body weight no less than 45.0kg, 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 6 months after the study completed; females of non-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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
VV119 Placebo （in healthy adult subjects）
DrugVV119 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.
VV119 （in healthy adult subjects）
DrugVV119 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.
VV119(in adult patients with schizophrenia)
DrugVV119 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.
VV119 Placebo （in adult patients with schizophrenia）
DrugVV119 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Part Ⅰ- in healthy adult subjectsExperimental treatment 2 interventions
Group B: Part Ⅱ-in adult patients with schizophreniaExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Time frame
Baseline to 15 days after the last administrationSecondary outcomes
1
Cmax
maximum observed plasma concentration of VV119 and the main metabolites
Time frame
Baseline to 360 hours after the last administration2
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
Time frame
Baseline to 360 hours after the last administration3
AUC0-∞
area under the plasma concentration time curve from time zero to infinity of VV119 and the main metabolites
Time frame
Baseline to 360 hours after the last administration4
Tmax
time at which Cmax occurs of VV119 and the main metabolites of VV119 and the main metabolites
Time frame
Baseline to 360 hours after the last administrationSponsors and contacts
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Source ClinicalTrials.gov