Ikaria completes dosing of Phase Ia sodium sulfide for injection study

The study was a Phase I, randomized, single blind, placebo-controlled, single center dose escalation study of a single bolus injection of IK-1001 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. Subjects were monitored for adverse events. 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. The trial was conducted in Melbourne, Australia and involved a total of 36 healthy volunteers.

Ralf Rosskamp, executive vice president of research and development at Ikaria, said: “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.”