Single Dose Escalation Study of ONO-9054 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Adult Subjects
• Interventions: Drug: ONO-9054

• Registration Number: NCT01508988
• Lead Sponsor: Ono Pharma USA Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-12
• Primary Completion: 2012-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eye drops 0.3 µg/mL	ONO-9054	-
Eye drops 1 µg/mL	ONO-9054	-
Eye drops 30 µg/mL	ONO-9054	-
Eye drops 3 µg/mL	ONO-9054	-
Eye drops 20 µg/mL	ONO-9054	-
Eye drops 10 µg/mL	ONO-9054	-
Eye drops placebo	ONO-9054	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Covance Phase 1 Unit; 🇺🇸 Dallas, Texas, United States