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
Qualifiers
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
Treatments tested in this trial
- VV119 Placebo （in healthy adult subjects）
- VV119 （in healthy adult subjects）
- VV119(in adult patients with schizophrenia)
- VV119 Placebo （in adult patients with schizophrenia）
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov