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 tablets after multiple ascending doses administered orally to Chinese healthy volunteers.
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 groups (200mg, 400mg, 600mg), investigational product is orally administrated BID for 5.5 days, the last dose is taken in D6 morning. When 7th day visit after last dose (D12) is completed for previous dose group, investigator and sponsor will evaluate the safety and determine whether the next dose group can be started. 12 subjects will be enrolled in each dose group and the ratio of investigational product to placebo is 3:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Drug: VV116 9 subjects will receive VV116 200 mg, orally, QD12h, 5.5 days ;
Drug: VV116 9 subjects will receive VV116 400 mg, orally, QD12h, 5.5 days ;
Drug: VV116 9 subjects will receive VV116 600 mg, orally, QD12h, 5.5 days ;
Shanghai Xuhui Central Hospital
Shanghai, China
Number of participants with treatment emergent treatment-related adverse event(s)
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Time frame: Dosing through follow-up call (7 days after last dose of investigational product)
Number of participants with laboratory test findings of potential clinical importance
Time frame: Dosing through follow-up call (7 days after last dose of investigational product)
Number of participants with vital signs findings of potential clinical importance
Time frame: Dosing through follow-up call (7 days after last dose of investigational product)
Number of participants with ECG findings of potential clinical importance
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Time frame: Dosing through follow-up call (7 days after last dose of investigational product)
Tmax
Time to reach maximum observed plasma concentration
Time frame: Calculated using concentration data collected from predose to 48 hours postdose
Cmax
Maximum observed plasma concentration
Time frame: Calculated using concentration data collected from predose to 48 hours postdose
T1/2
Terminal half life
Time frame: Calculated using concentration data collected from predose to 48 hours postdose
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AUC0-T
Calculated using concentration data collected from predose to 48 hours postdose
Time frame: Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration.
AUC0-∞
Area under the plasma concentration-time curve from time 0 extrapolated to infinity
Time frame: Calculated using concentration data collected from predose to 48 hours postdose