The primary objective of this study is to evaluate the safety and tolerability of ascending single doses of ONO-9054 administered as a single drop in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to evaluate the pharmacodynamic (PD) profile.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Covance Phase 1 Unit
Dallas, Texas, United States
Safety and tolerability of ONO-9054 using vital signs, ECGs, laboratory tests, ocular exams, spirometry, physical examinations and incidence/severity of adverse events
Time frame: up to 4 days
1. Characterization of PK profiles of ONO-9054 and metabolite through measurement of drug concentration in plasma sample
Time frame: up to 2 days
2. Pharmacodynamic evaluation of ophthalmic effects by measuring the degree and duration of intraocular pressure lowering
Time frame: up to 2 days
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Eye drops 10 µg/mL both eyes on Day one
Eye drops 20 µg/mL both eyes on Day one
Eye drops 30 µg/mL both eyes on Day one
Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one