NCT01508988
Completed
Phase 1
A Double-masked Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONO-9054 in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- ONO-9054
- Conditions
- Healthy Adult Subjects
- Sponsor
- Ono Pharma USA Inc
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of ONO-9054 using vital signs, ECGs, laboratory tests, ocular exams, spirometry, physical examinations and incidence/severity of adverse events
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Eye drops 0.3 µg/mL
Intervention: ONO-9054
Eye drops 1 µg/mL
Intervention: ONO-9054
Eye drops 3 µg/mL
Intervention: ONO-9054
Eye drops 10 µg/mL
Intervention: ONO-9054
Eye drops 20 µg/mL
Intervention: ONO-9054
Eye drops 30 µg/mL
Intervention: ONO-9054
Eye drops placebo
Intervention: ONO-9054
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
Study Sites (1)
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