NCT01508988

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Ono Pharma USA Inc · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-04-01
• First posted: 2012-01-12
• Last updated: 2012-06-14

Locations

1 site across 1 country: United States