Status:
COMPLETED
Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV116 in Healthy Volunteers
Lead Sponsor:
Vigonvita Life Sciences
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blinded, placebo-controlled, single-center phase I clinical trial. The objective of this study is to evaluate the safety, tolerability, pharmacokinetic profiles of VV116 t...
Detailed Description
Multiple-dose ascending design is used in the trial, VV116/Placebo is administered sequentially from low-dose to high-dose and each subject can only orally receive one dose level. There are 3 dose gro...
Eligibility Criteria
Inclusion
- Healthy subjects between the ages of 18 and 45 years;
- Body weight no less than 50 kg for male, no less than 45 kg for female; Body Mass Index of 19 to 26kg/m2;
- Physical examination, vital signs examination, laboratory examination, ECG, B-ultrasound and fundus examination results were normal or abnormal without clinical significant;
- Subjects who are willing to take proper contraceptive during the study and within 3 months after the study completed;
- 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;
Exclusion
- Subjects with hypersensitivity to VV116 or any of the excipients;
- Subjects with allergic diseases or allergic constitution;
- Subjects with central nervous system,cardiovascular system,gastrointestinal, respiratory system,urinary,Hematologic System,metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;
- Blood donation or blood loss ≥ 400 mL within 3 months prior to inclusion, or have a history of blood product use history;
- Participated in a clinical study involving another investigational drug within 3 month before the screening visit;
- Taken any prescription drugs, non-prescription drugs, Chinese herbal medicine or health care products within 2 weeks prior to screening;
- Drug or alcohol addicts within 1 year prior to screening, who drink at least twice a day or more than 14 units per week, or who are addicted to alcohol (1 unit ≈200 mL beer with 5% alcohol content, 25 mL spirits with 40% alcohol content or 85 mL wine with 12% alcohol content) ;
- Those who smoke more than 10 cigarettes per day and do not agree to avoid using any tobacco products during the trial period;
- Those who cannot quit smoking or drinking during the trial;
- Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
- Abnormal and clinically significant chest radiographs (anteroposterior);
- B ultrasound examination showed moderate to severe fatty liver;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeded the upper normal limit (ULN) at screening time or baseline;
- Glomerular filtration rate (eGFR) \< 90 mL/min/1.73m2 at screening time or baseline;
- Abnormal ecg at screening or baseline, single QTcF (corrected for heart rate) \> 450 ms in men, \> 470 ms in women, and/or other clinically significant abnormalities;
- Pregnant or lactating women or male subjects whose spouse has a child care plan within 3 months;
- The investigator believes that there are other factors that are not suitable for participating in this trial.
Key Trial Info
Start Date :
December 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05201690
Start Date
December 14 2021
End Date
January 23 2022
Last Update
February 9 2022
Active Locations (1)
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1
Shanghai Xuhui Central Hospital
Shanghai, China