Last reviewed · How we verify
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
Phase 1 trial testing INO-8875 in Health in 70 participants. Completed in 1 February 2011.
1 February 2011
Quick facts
| Lead sponsor | Inotek Pharmaceuticals Corporation |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 1 May 2010 |
| Primary completion | 1 February 2011 |
| Estimated completion | 1 February 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- INO-8875 — full drug profile →
- Placebo control
Conditions studied
- Health — all drugs for Health →
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.
-
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 14 days
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):
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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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT01123772
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Inotek Pharmaceuticals Corporation trials
Trials by the same sponsor.
- NCT02829996 — Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01123772 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Inotek Pharmaceuticals Corporation
- Last refreshed: 27 April 2012
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