This is a single-center, double-masked, randomized, vehicle-controlled study conducted in China in adult healthy subjects
This is a Phase I, randomized, double-masked, vehicle-controlled study to evaluate the safety, tolerability and pharmacokinetics of 0.25%, 0.5% and 1.0% VVN461 Ophthalmic Solution in healthy male and female volunteers in China. The study consisted of a screening period (D-7 to D-1), a baseline visit (D-1), a single-dose period (D1), QID multi-dose period (D2 to D5), six times daily multi-dose period (D6 to D9), discharge (D10), and a follow-up/EOS (D16,+1D). During the single-dose period, subjects will receive one drop of VVN461 eye drops (0.25%, 0.5%, or 1.0%) or vehicle in the study eye. For the multi-dose period, subjects will receive one drop of VVN461 eye drop (0.25%, 0.5% or 1.0%) or vehicle in the study eye four or six times a day. PK blood samples will be collected before and after dosing at D1, D5 and D9.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
VVN461, 1.0%
VVN461, 0.5%
VVN461, 0.25%
Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Safety outcome
Incidence of adverse events
Time frame: Baseline to Day 16
Time to maximum blood level
Tmax
Time frame: Maximum seen over Days 1 to 9
Area under the curve of blood levels until last observation
AUC0-last
Time frame: Integrated over Days 1 to 9
Area under the curve of blood levels extrapolated to infinity
AUC0-inf
Time frame: Integrated over Days 1 to 9
Half life of drug in blood
t1/2
Time frame: Integrated over Days 1 to 9
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vehicle