The FDA approved MedRegen’s IND application for a phase 1/2 combined clinical trial targeting COVID-19 patients. MedRegen initiated its first clinical trial in January 2021, a phase 1 double-blind randomized placebo-controlled study in healthy subjects to assess the safety, pharmacokinetics and pharmacodynamics of MRG-001. The trial included a total of 18 healthy subjects. Three dose levels were tested, with 6 subjects per arm of which 4 were MRG-001 treated and 2 placebo. The dose ranging is intended to find the optimal dose for sufficient stem cell mobilization. The primary endpoint for this study is the proportion of subjects experiencing any treatment emergent adverse events associated with MRG-001 to day 12.
For more details on the clinical trial, please visit: MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 patients.