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

NCT01123772 — Phase 1, Completed, 70 participants, Inotek Pharmaceuticals Corporation

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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

Registry	NCT01123772
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	70 (Actual)
Sponsor	Inotek Pharmaceuticals Corporation (Industry)
Conditions	Health
Interventions	INO-8875, Placebo control (Drug, other)
Dates	start 2010-05-01, primary completion 2011-02-01, completion 2011-02-01, first posted 2010-05-14, last updated 2012-04-30
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Control	Placebo comparator	Other: Placebo control	Vehicle control
INO-8875	Experimental	Drug: INO-8875	Active drug

INO-8875 (Drug): eye drops for 14 days in one eye
Placebo control (Other): Matched placebo

+Outcome measures

Primary outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [14 days]

+Eligibility

Sex: All, ages: 35 Years to 65 Years, 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

+Locations (1)

Facility	City	Country	Status
	Evansville, Indiana	United States