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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye drops 0.3 µg/mL | Experimental |
| |
| Eye drops 1 µg/mL | Experimental |
| |
| Eye drops 3 µg/mL | Experimental |
| |
| Eye drops 10 µg/mL | Experimental |
| |
| Eye drops 20 µg/mL | Experimental |
| |
| Eye drops 30 µg/mL | Experimental |
| |
| Eye drops placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-9054 | Drug | Eye drops 0.3 µg/mL both eyes on Day one |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of ONO-9054 using vital signs, ECGs, laboratory tests, ocular exams, spirometry, physical examinations and incidence/severity of adverse events | up to 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Characterization of PK profiles of ONO-9054 and metabolite through measurement of drug concentration in plasma sample | up to 2 days | |
| 2. Pharmacodynamic evaluation of ophthalmic effects by measuring the degree and duration of intraocular pressure lowering |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Pharma USA, Inc. | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Phase 1 Unit | Dallas | Texas | 75247 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26720443 | Derived | Suto F, Rowe-Rendleman CL, Ouchi T, Jamil A, Wood A, Ward CL. A Novel Dual Agonist of EP3 and FP Receptors for OAG and OHT: Safety, Pharmacokinetics, and Pharmacodynamics of ONO-9054 in Healthy Volunteers. Invest Ophthalmol Vis Sci. 2015 Dec;56(13):7963-70. doi: 10.1167/iovs.15-18166. |
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| ID | Term |
|---|---|
| C000607345 | propan-2-yl 4-(6-(4-(2,5-difluorophenoxy)-3-hydroxybut-1-en-1-yl)-7-hydroxyoctahydro-2H-cyclopenta(b)oxepin-3-yl)butanoate |
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| ONO-9054 |
| Drug |
Eye drops 1 µg/mL both eyes on Day one |
|
| ONO-9054 | Drug | Eye drops 3 µg/mL both eyes on Day one |
|
| ONO-9054 | Drug | Eye drops 10 µg/mL both eyes on Day one |
|
| ONO-9054 | Drug | Eye drops 20 µg/mL both eyes on Day one |
|
| ONO-9054 | Drug | Eye drops 30 µg/mL both eyes on Day one |
|
| ONO-9054 | Drug | Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one |
|
| up to 2 days |