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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01123772

Enrollment

Registered

2010-05-14

Start date

2010-05-31

Completion date

2011-02-28

Last updated

2012-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health

Keywords

adenosine agonist, eye drop, elderly volunteer, older healthy volunteer

Brief 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.

Interventions

DRUGINO-8875

eye drops for 14 days in one eye

OTHERPlacebo control

Matched placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 65 Years

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

* 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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026