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)]
Life Biosciences Inc.
Summary
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
Description
This first-in-human (FIH), Phase 1 clinical trial is designed to evaluate the safety and tolerability of ER-100, an investigational epigenetic therapy candidate intended for age-related optic neuropathies, such as Open Angle Glaucoma (OAG) and Non Arteritic Anterior Ischemic Optic Neuropathy(NAION) Over time, factors such as age, disease, injury, and lifestyle can leave marks on cells that affect how genes function. These marks, known as epigenetic changes, may contribute to cellular decline. ER-100 is designed to address cellular aging through epigenetic reprogramming. It works by delivering…