Single Dose Escalation Study of ONO-9054 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01508988

Enrollment

Registered

2012-01-12

Start date

2012-01-31

Completion date

Unknown

Last updated

2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Subjects

Keywords

ONO-9054, adult healthy volunteers, single dose, phase 1

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.

Interventions

DRUGONO-9054

Eye drops 0.3 µg/mL both eyes on Day one

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026