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ONO-9054

Phase 1

Healthy Adult Subjects | Small molecule | Other |BrainsWay Ltd.|Last Updated: Jun 14, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

ONO-9054 · 1 trial · 1 indication

Phase 1 1
NCT01508988Single Dose Escalation Study of ONO-9054 in Healthy VolunteersHealthy Adult Subjects
COMPLETED48 Analytics
PHASE1COMPLETED
Single Dose Escalation Study of ONO-9054 in Healthy Volunteers
Healthy Adult Subjects
NCT0150898848
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Eye drops 0.3 µg/mLEXPERIMENTAL -
Eye drops 1 µg/mLEXPERIMENTAL -
Eye drops 3 µg/mLEXPERIMENTAL -
Eye drops 10 µg/mLEXPERIMENTAL -
Eye drops 20 µg/mLEXPERIMENTAL -
Eye drops 30 µg/mLEXPERIMENTAL -
Eye drops placeboEXPERIMENTAL -

Interventions

NameTypeDescription
ONO-9054DRUGEye drops 0.3 µg/mL both eyes on Day one
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

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) ...

Countries:United States
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Frequently asked questions about ONO-9054

What is ONO-9054 used for?

ONO-9054 is an investigational small molecule being studied for use in healthy adult subjects. It is currently in Phase 1 clinical development, with a completed single dose escalation study in healthy volunteers. The drug is not approved and remains under investigation.

Who makes ONO-9054?

ONO-9054 is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The drug is in Phase 1 clinical development, and the developer is conducting trials to evaluate its safety and tolerability in healthy adult subjects.

What phase is ONO-9054 in?

ONO-9054 is in Phase 1 clinical development. A single dose escalation study in healthy volunteers has been completed. The drug is investigational and has not been approved for any use, as it is still in early-stage clinical trials.

What clinical trials is ONO-9054 in?

ONO-9054 has one completed clinical trial, NCT01508988, titled "Single Dose Escalation Study of ONO-9054 in Healthy Volunteers." This Phase 1 study enrolled 48 participants in the United States and was a randomized, double-blind, controlled trial.

Is ONO-9054 FDA approved?

ONO-9054 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A single dose escalation study in healthy volunteers has been completed, but the drug remains under investigation and has not been approved for any medical use.