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NCT01123772

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

Completed Phase 1 Last updated 27 April 2012
What this trial tests

Phase 1 trial testing INO-8875 in Health in 70 participants. Completed in 1 February 2011.

Timeline
1 May 2010
Primary endpoint
1 February 2011
1 February 2011

Quick facts

Lead sponsorInotek Pharmaceuticals Corporation
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment70
Start date1 May 2010
Primary completion1 February 2011
Estimated completion1 February 2011
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Inotek Pharmaceuticals Corporation — full company profile →

Who can join

Adults 35 to 65, any sex, with Health. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Potential for developing purinergic drugs for gastrointestinal diseases.
    Ochoa-Cortes F, Liñán-Rico A, Jacobson KA, Christofi FL. · · 2014 · cited 46× · PMID 24859298 · DOI 10.1097/mib.0000000000000047
  2. Targeting Schlemm's Canal in the Medical Therapy of Glaucoma: Current and Future Considerations.
    Andrés-Guerrero V, García-Feijoo J, Konstas AG. · · 2017 · cited 26× · PMID 28349508 · DOI 10.1007/s12325-017-0513-z
  3. A Randomized Phase 1 Dose Escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Trabodenoson in Healthy Adult Volunteers.
    Laties A, Rich CC, Stoltz R, Humbert V, et al · · 2016 · cited 14× · PMID 27046445 · DOI 10.1089/jop.2015.0147

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Other recruiting trials for Health

Currently open trials in the same condition.

Other Inotek Pharmaceuticals Corporation trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01123772.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing