Phase I Dose-Escalation Study to Evaluate Tolerability, Safety & PK of INO-8875 in Healthy Older-Adult Volunteers

Phase I, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate Tolerability, Safety & PK of BID Topical Ocular Application of INO-8875 in Healthy Older-Adult Volunteers

The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye drops at different concentrations to normal older healthy adult volunteers for two weeks.

Inclusion Criteria:

• male, or a female with a negative pregnancy test and without childbearing potential
• aged 35 to 65 years
• body weight is ≥50 kg and ≤115 kg

Exclusion Criteria:

• Subject has glaucoma or any active ophthalmologic disease including conjunctivitis
• Subject has a central retinal vein occlusion in either eye at any time in the past
• Subject is currently on any drug that might affect IOP including oral or ocular glucocorticoids or ephedrine
• Subject has history of ocular trauma or surgery (except for non-incisional surgery performed at least 3 months prior to the Screening visit)
• Subject has a prosthetic eye or any ocular abnormality precluding reliable applanation tonometry in either eye including an immobile pupil.
• Subject is not able to refrain from use of contact lenses during the Treatment Period