Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
21
Once daily from day 1 to day 8; Everyday, subject will be administered with 1 drop in each eye followed by another drop in each eye 2 minutes later
Once daily from day 1 to day 8; Everyday, subject will be administered with 1 drop in each eye followed by another drop in each eye 2 minutes later
Once daily from day 1 to day 8; Everyday, subject will be administered with 1 drop in each eye followed by another drop in each eye 2 minutes later
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Cmax
Maximum plasma concentrations of LNZ100 and LNZ101
Time frame: Day 1 and Day 8
Tmax
Time of maximum plasma concentrations of LNZ100 and LNZ101
Time frame: Day 1 and Day 8
AUC0-t
Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100
Time frame: Day 1 and Day 8
AUC0-∞
Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101
Time frame: Day 1 and Day 8
T1/2
Terminal half-life of LNZ100 and LNZ101
Time frame: Day 1 and Day 8
Safety: adverse event reporting
The number of patients who experience one or more AE during the treatment period
Time frame: up to 23 days
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