Single Dose Escalation Study of ONO-9054 in Healthy Volunteers

Ono Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy Adult Subjects

Treatments

Drug: ONO-9054

Study type

Interventional

Funder types

Industry

Identifiers

NCT01508988

ONO-9054IOU001

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 7 patient groups

Eye drops 0.3 µg/mL

Experimental group

Treatment:

Drug: ONO-9054

Eye drops 1 µg/mL

Experimental group

Treatment:

Drug: ONO-9054

Eye drops 3 µg/mL

Experimental group

Treatment:

Drug: ONO-9054

Eye drops 10 µg/mL

Experimental group

Treatment:

Drug: ONO-9054

Eye drops 20 µg/mL

Experimental group

Treatment:

Drug: ONO-9054

Eye drops 30 µg/mL

Experimental group

Treatment:

Drug: ONO-9054

Eye drops placebo

Experimental group

Treatment:

Drug: ONO-9054

Trial contacts and locations

1

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