This study will consist of 2 parts: Part Ⅰ - Single Ascending Dose (SAD) study, Part Ⅱ - Food Effect (FE) study
Part Ⅰ were designed as single-center, randomized, double-blind, placebo-controlled, dose-escalation trials to assess the safety, tolerability, pharmacokinetic (PK) of single oral doses of VV119 in healthy adult subjects. Part Ⅱ is a single-center, randomized, open label, 2×2 crossover design to assess the high-fat meal effects on PK of a single oral dose of VV119 in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
VV119 0.2 mg Group: 2 subjects will receive VV119 0.2 mg, orally; VV119 0.5 mg Group: 6 subjects will receive VV119 0.5 mg, orally; VV119 1 mg Group: 6 subjects will receive VV119 1 mg, orally; VV119 2 mg Group: 6 subjects will receive VV119 2 mg, orally; VV119 3 mg Group:6 subjects will receive VV119 3 mg, orally; VV119 4.5 mg Group:6 subjects will receive VV119 4.5 mg, orally; VV119 6 mg Group:6 subjects will receive VV119 6 mg, orally; VV119 8 mg Group:6 subjects will receive VV119 8 mg, orally; VV119 10 mg Group:6 subjects will receive VV119 10 mg, orally;
VV119 0.5 mg Group: 2 subjects will receive VV119 Placebo 0.5 mg, orally; VV119 1 mg Group: 2 subjects will receive VV119 Placebo 1 mg, orally; VV119 2 mg Group: 2 subjects will receive VV119 Placebo 2 mg, orally; VV119 3 mg Group:2 subjects will receive VV119 Placebo 3 mg, orally; VV119 4.5 mg Group:2 subjects will receive VV119 Placebo 4.5 mg, orally; VV119 6 mg Group:2 subjects will receive VV119 Placebo 6 mg, orally; VV119 8 mg Group:2 subjects will receive VV119 Placebo 8 mg, orally; VV119 10 mg Group:2 subjects will receive VV119 Placebo 10 mg, orally;
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGIncidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Time frame: 23 days after treatment in part Ⅰ;
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Time frame: 56 days after treatment in part Ⅱ;
Cmax
maximum observed plasma concentration of VV119 and the main metabolites
Time frame: 360 hours after dosing in part Ⅰ;
Cmax
maximum observed plasma concentration of the main metabolites VV119-M2
Time frame: 480 hours after dosing in part Ⅱ;
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: 360 hours after dosing in part Ⅰ;
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 the main metabolites VV119-M2
Time frame: 480 hours after dosing in part Ⅱ;
AUC0-∞
area under the plasma concentration time curve from time zero to infinity of VV119 and the main metabolites
Time frame: 360 hours after dosing in part Ⅰ;
AUC0-∞
area under the plasma concentration time curve from time zero to infinity of the main metabolites VV119-M2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
A:2 mg VV119, following an overnight fast of at least 10 hours for Period 1; 2mg VV119, administered 30 minutes after the start of a high-fat meal for Period 2; B: 2mg VV119, administered 30 minutes after the start of a high-fat meal for Period 1;2mg VV119, following an overnight fast of at least 10 hours for Period 2;
Time frame: 480 hours after dosing in part Ⅱ;
Tmax
time at which Cmax occurs of VV119 and the main metabolites of VV119 and the main metabolites
Time frame: 360 hours after dosing in part Ⅰ;
Tmax
time at which Cmax occurs of VV119 and the main metabolites of the main metabolites VV119-M2
Time frame: 480 hours after dosing in part Ⅱ;
t1/2
half life of elimination of VV119 and the main metabolites
Time frame: 360 hours after dosing in part Ⅰ;
t1/2
half life of elimination of the main metabolites VV119-M2
Time frame: 480 hours after dosing in part Ⅱ;
Apparent Clearance Rate(CL/F)
apparent clearance of VV119 and the main metabolites
Time frame: 360 hours after dosing in part Ⅰ;
Apparent Clearance Rate(CL/F)
apparent clearance of the main metabolites VV119-M2
Time frame: 480 hours after dosing in part Ⅱ;
Vd/F
apparent volume of distribution during the terminal phase of VV119 and the main metabolites
Time frame: 360 hours after dosing in part Ⅰ;
Vd/F
apparent volume of distribution during the terminal phase of the main metabolites VV119-M2
Time frame: 480 hours after dosing in part Ⅱ;
Ke
elimination rate constant of VV119 and the main metabolites
Time frame: 360 hours after dosing in part Ⅰ;
Ke
elimination rate constant of the main metabolites VV119-M2
Time frame: 480 hours after dosing in part Ⅱ;
mean Resident Time from time zero to the last(MRT0-t)
mean Resident Time from time zero to the last of VV119 of VV119 and the main metabolites
Time frame: 360 hours after dosing in part Ⅰ;
mean Resident Time from time zero to the last(MRT0-t)
mean Resident Time from time zero to the last of the main metabolites VV119-M2
Time frame: 480 hours after dosing in part Ⅱ;
mean Resident Time from time zero to infinity(MRT0-∞)
mean Resident Time from time zero to infinity of VV119 and the main metabolites
Time frame: 360 hours after dosing in part Ⅰ;
mean Resident Time from time zero to infinity(MRT0-∞)
mean Resident Time from time zero to infinity of the main metabolites VV119-M2
Time frame: 480 hours after dosing in part Ⅱ;
AUC_%Extra
area under plasma Concentration (AUC) extrapolated of VV119 and the main metabolites
Time frame: 360 hours after dosing in part Ⅰ;
AUC_%Extra
area under plasma Concentration (AUC) extrapolated of the main metabolites VV119-M2
Time frame: 480 hours after dosing in part Ⅱ;
BP
Blood Plasma Ratio of the main metabolites VV119-M2
Time frame: 360 hours after dosing in part Ⅰ;
BP
Blood Plasma Ratio of VV119 and the main metabolites
Time frame: 480 hours after dosing in part Ⅱ;
Metabolite Identification
Identification of the structure of the main metabolites of VV119 in plasma,Urine and feces
Time frame: 360 hours after dosing