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

Inotek Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Health

Treatments

Other: Placebo control

Drug: INO-8875

Study type

Interventional

Funder types

Industry

Identifiers

NCT01123772

IPC-09-2009

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

35 to 65 years old

Volunteers

Accepts Healthy Volunteers

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