CompletedNCT01123772Updated Apr 30, 2012

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

A Phase 1 interventional study of INO-8875 and Placebo control in Health, sponsored by Inotek Pharmaceuticals Corporation. Completed at 1 site in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-30.

Sponsored by Inotek Pharmaceuticals Corporation · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 35 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Health

Keywords

adenosine agonist
eye drop
elderly volunteer
older healthy volunteer

In context

Lead sponsor

Inotek Pharmaceuticals Corporation is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 35 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 70 participants (actual)

Study arms

Placebo comparator
Control
Vehicle control
Other: Placebo control
Experimental
INO-8875
Active drug
Drug: INO-8875

Interventions

DrugINO-8875
eye drops for 14 days in one eye
OtherPlacebo control
Matched placebo

What researchers measure

Primary outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 14 days

Study locations

1 site

Evansville, Indiana, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01123772
Lead sponsor: Inotek Pharmaceuticals Corporation
Responsible party: Sponsor
First posted: May 14, 2010
Start date: May 2010
Primary completion: Feb 2011
Completion: Feb 2011
Last update: Apr 30, 2012

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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