Phase 1Recruiting
Evaluating ER-100 for Safety in People With Glaucoma or Non-Arteritic Anterior Ischemic Optic Neuropathy (Optic Nerve Conditions)
A Phase 1 Single Dose Study to Evaluate the Safety and Tolerability of ER-100 in Optic Neuropathies [Open Angle Glaucoma (OAG) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)]
- Sponsor
- Life Biosciences Inc. (Industry)
- Enrolment
- 18 planned
- Conditions
- Open Angle Glaucoma (OAG); NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)
- Interventions
- ER-100 epigenetic therapy
- Ages
- adults, older adults
- Registry
- NCT07290244
From the registry
The goal of this clinical trial is to evaluate the safety and tolerability of a single dose of ER-100 in adults with optic nerve conditions, specifically Open Angle Glaucoma (OAG) and Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION). The main questions it aims to answer are: * Is ER-100 safe when given as a single dose to people with OAG or NAION * What side effects may occur, if any, after taking ER-100? Participants will: * Receive a single dose of ER-100 * Undergo safety assessments including detailed eye examination and laboratory tests * Provide body fluid samples (tears, saliva, feces, urine) to help researchers understand how the drug is processed and cleared from the body * Complete questionnaires about their quality of life * Be followed for up to 5 years to monitor long-term health and vision outcomes
Primary outcomes
- Incidence of Treatment-Emergent Adverse Events (TEAEs) During and Post-Doxycycline Activation Period
- Incidence of Dose-Limiting Toxicities During and Post-Doxycycline Activation Period
- Change in Safety Laboratory Tests (Liver Function Tests - LFTs) During and Post-Doxycycline Activation Period
- Change in Safety Laboratory Tests (Blood Protein Levels) During and Post-Doxycycline Activation Period