The trial includes four groups of 10 subjects each to assess the safety of escalating doses of RGN-352 injected into the blood stream. A final analysis and report will be completed after 28 days of follow-up of the last subject.
RegeneRx expects to initiate the second part of Phase I with a Phase Ib trial in the third quarter 2008 after submitting a Ia report to the FDA. The Ib trial design is similar to Ia; however, the 40 subjects will be dosed once daily for 14 days, rather than given only a single dose, and will undergo a 28-day and a six-month follow-up.
Finkelstein, president and CEO of Regenerx, said: “This trial is intended to provide the safety data for Phase II clinical trials that are being planned to evaluate RGN-352 for the treatment of patients immediately after an acute myocardial infarction and also to support other potential uses of RGN-352 in medical indications where short-term systemic administration of the drug candidate may be warranted.”