Single Dose Escalation Study of ONO-9054 in Healthy Volunteers

Phase 1 Completed 48 enrolled Ono Pharma USA Inc

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2012-01
Primary completion: 2012-04
Completion: —

Publications

Suto F, Rowe-Rendleman CL, Ouchi T, Jamil A, Wood A, Ward CL. A Novel Dual Agonist of EP3 and FP Receptors for OAG and OHT: Safety, Pharmacokinetics, and Pharmacodynamics of ONO-9054 in Healthy Volunteers. Invest Ophthalmol Vis Sci. 2015 Dec;56(13):7963-70. doi: 10.1167/iovs.15-18166.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sepetaprost	Small molecule	0.3 ug/ml	Other
Subject	Sepetaprost	Small molecule	1 ug/ml	Other
Subject	Sepetaprost	Small molecule	3 ug/ml	Other
Subject	Sepetaprost	Small molecule	10 ug/ml	Other
Subject	Sepetaprost	Small molecule	20 ug/ml	Other
Subject	Sepetaprost	Small molecule	30 ug/ml	Other

Indications

No indication recorded.