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Single Dose Escalation Study of ONO-9054 in Healthy Volunteers

NCT01508988 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-06-14

No results posted yet for this study

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.

Conditions

  • Healthy Adult Subjects

Interventions

DRUG

ONO-9054

Eye drops 0.3 µg/mL both eyes on Day one

DRUG

ONO-9054

Eye drops 1 µg/mL both eyes on Day one

DRUG

ONO-9054

Eye drops 3 µg/mL both eyes on Day one

DRUG

ONO-9054

Eye drops 10 µg/mL both eyes on Day one

DRUG

ONO-9054

Eye drops 20 µg/mL both eyes on Day one

DRUG

ONO-9054

Eye drops 30 µg/mL both eyes on Day one

DRUG

ONO-9054

Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one

Sponsors & Collaborators

  • Ono Pharma USA Inc

    lead INDUSTRY

Principal Investigators

  • Ono Pharma USA, Inc. · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01508988 on ClinicalTrials.gov