A Phase 1 interventional study of LNZ101 (Aceclidine /Brimonidine) ophthalmic solution and LNZ100 (Aceclidine) ophthalmic solution in Presbyopia, sponsored by Corxel Pharmaceuticals. Completed at 1 site in China. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Corxel Pharmaceuticals · Phase 1, Interventional, and Treatment
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
324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.
This study's enrollment of 21 is below the median of 61 across 265 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Corxel Pharmaceuticals is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Aceclidine/Brimonidine ophthalmic solution Other Names: LNZ101
Drug: LNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Drug: Aceclidine ophthalmic solution Other Names: LNZ100
Drug: LNZ100 (Aceclidine) ophthalmic solution
Drug: Placebo (Vehicle) ophthalmic solution Other Names: NA
Drug: Placebo (Vehicle) ophthalmic solution
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
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
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Corxel Pharmaceuticals