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

Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123772
• Other study ID #: IPC-09-2009
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2010
• Last updated: April 27, 2012
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: April 2012
• Source: Inotek Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Health

Intervention

Drug:
• INO-8875
eye drops for 14 days in one eye

Other:
• Placebo control
Matched placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inotek Pharmaceuticals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		14 days	Yes