Safety and Effectiveness Study of Oral EC5026 in Adults Aged 50 to 80 with Parkinsons Disease

What this Trial Is About

Researchers are evaluating the safety and effects of the oral drug EC5026 in adults aged 50 to 80 years with Parkinsons Disease. This Phase 1b study examines whether EC5026 targets the intended biological pathways and the levels of the drug in blood and spinal fluid after daily use. The study also explores if EC5026 may improve Parkinsons symptoms, comparing the drug to a placebo in a randomized, double-blind design. Participants will take either 2 mg or 4 mg of EC5026 orally once daily for 28 days or receive a matching placebo. The study involves two dose regimens given over consecutive days and includes frequent clinic visits for monitoring. The drug works by inhibiting an enzyme linked to inflammation, aiming to prolong natural anti-inflammatory agents in the body. Placebo controls help determine the drugs specific effects. During the study, participants will have regular checkups, blood draws, spinal fluid tests, and complete questionnaires to assess safety and drug levels. Researchers will track any adverse events and serious side effects over 56 days. The study also monitors participants Parkinsons symptoms and collects laboratory and ECG data. Participation lasts through the dosing period and follow-up to assess tolerability and exploratory benefits.

Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)