Ikaria completes dosing for Phase Ia cardiac trial

The study was a Phase I, randomized, single blind, placebo-controlled, single center dose escalation study of a single bolus injection of IK-1001 (sodium sulfide) in healthy volunteers to assess safety, tolerability and pharmacokinetics. The study comprised five dosing cohorts of 0.005mg/kg, 0.01mg/kg, 0.03mg/kg, 0.06mg/kg and 0.1mg/kg with four subjects in the first cohort and eight subjects in the remaining cohorts.

Blood and urine were sampled to determine pharmacokinetic profiles. Doses evaluated were expected to be within the therapeutic window based on preclinical animal models. At the doses tested, no adverse reactions were observed that were of clinical significance, and no clinical laboratory abnormalities were detected.

Ralf Rosskamp, managing director, executive vice president for research and development of Ikaria, said: “We are very pleased with these preliminary results, which suggest that IK-1001 is a well tolerated drug at the doses tested in healthy volunteers. Pre-clinical data have demonstrated the therapeutic potential of sodium sulfide for injection as a treatment for multiple hypoxic/ischemic conditions, including myocardial infarction, cardiopulmonary bypass surgery, and acute lung injury.”