Single Dose Escalation Study of ONO-9054 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Double-masked Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONO-9054 in Healthy Adult Subjects

Conditions
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Healthy Adult Subjects

Intervention / Treatment
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* Drug: ONO-9054
* Drug: ONO-9054
* Drug: ONO-9054
* Drug: ONO-9054
* Drug: ONO-9054
* Drug: ONO-9054
* Drug: ONO-9054


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subjects, aged 18-64 inclusive Body mass index (BMI) of 19-35 kg/m2 (inclusive) IOP measurement oculus uterque (OU, both eyes) < 21 mm Hg (inclusive) at screening and Day -1 Best corrected visual acuity (BCVA) 20/30 or better (Snellen Equivalent) at both the screening visit and Day -1 Exclusion Criteria: Any history of severe ocular trauma in either eye at any time Any history of previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of the screening visit in either eye Current or chronic history of ocular infection within the past 3 months of screening visit in either eye OR ongoing or recurrent ocular inflammation in either eye At the ophthalmic investigator's discretion, any subjects who have a history of any significant ocular conditions in either eye that would contraindicate the use of the study medication, or that might affect the study conduct, or the interpretation of the study results Use of any non-diagnostic topical ophthalmic solutions except for sponsor-recommended tear substitutes from admission to the study unit through the duration of the study History of clinically significant drug or food allergy, positive HIV, hepatitis B or C at screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eye drops 0.3 µg/mL<br> | Drug: ONO-9054<br>* Eye drops 0.3 µg/mL both eyes on Day one<br>|
| Experimental: Eye drops 1 µg/mL<br> | Drug: ONO-9054<br>* Eye drops 1 µg/mL both eyes on Day one<br>|
| Experimental: Eye drops 3 µg/mL<br> | Drug: ONO-9054<br>* Eye drops 3 µg/mL both eyes on Day one<br>|
| Experimental: Eye drops 10 µg/mL<br> | Drug: ONO-9054<br>* Eye drops 10 µg/mL both eyes on Day one<br>|
| Experimental: Eye drops 20 µg/mL<br> | Drug: ONO-9054<br>* Eye drops 20 µg/mL both eyes on Day one<br>|
| Experimental: Eye drops 30 µg/mL<br> | Drug: ONO-9054<br>* Eye drops 30 µg/mL both eyes on Day one<br>|
| Experimental: Eye drops placebo<br> | Drug: ONO-9054<br>* Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | up to 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ONO-9054, adult healthy volunteers, single dose, phase 1