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news.RegeneRx Biopharmaceuticals has enrolled the first subject in its Phase Ib clinical trial in which RGN-352 is being tested in 40 healthy subjects. RGN-352 is an injectable formulation being developed to reduce cardiac damage in patients after an acute myocardial infarction, as well as for other potential systemic uses.
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The double-blind, placebo-controlled dose-escalating trial includes four groups of 10 subjects each to assess the safety of multiple doses at escalating concentrations of RGN-352 injected into the blood stream. Each person will have a 28-day post-treatment assessment with a six-month follow-up.
Previously, RegeneRx has completed a Phase Ia trial in which a single dose of RGN-352, escalating over increasing concentrations, was deemed to be safe and well-tolerated.
David Crockford, vice president of clinical and regulatory affairs at RegeneRx, said: “We are pleased to begin the last part of our Phase I program to evaluate RGN-352 administered over a period of 14 days at escalating dose concentrations. We believe that the Phase I trial will provide strong safety and pharmacokinetic data and help us design Phase II trials to evaluate RGN-352 for the treatment of patients after an acute myocardial infarction, as well as for other potential indications.”