Recce Pharmaceuticals has received approval from an Independent Safety Committee for next cohort dosing in Phase I/II clinical trial of RECCE 327 (R327) at two faster infusion rates of 3,000mg to treat urinary tract infection (UTI) or urosepsis.
The company completed enrolling subjects for the next cohort and anticipates dosing them shortly.
The initiation of dosage at two faster infusion rates of 3,000mg is based on the review of the complete cohort dosing data of R327 at two faster infusion rates of 2,500mg through IV administration by the independent safety committee.
It was found to be safe and well-tolerated.
The single centre, adaptive design, open-label, two period crossover study of four cohorts included four participants at each dose level. They were administered with different doses.
Healthy male and female volunteers were enrolled from sites in New South Wales and South Australia.
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The first cohort received a single dose of R327, 2500mg at a dose concentration of 8mg/ml, intravenously (IV) for 45 minutes, followed by 48 hours of safety surveillance and pharmacokinetic data collection.
All participants received a second dose of R327, 2,500mg at the same dose concentration by IV for 30 minutes and with a minimum time elapsed of 48 hours.
The remaining cohorts including two to four will receive the dose within a range of 2,000mg to 3,000mg, and R327 concentration will range from 4mg/ml to 8mg/ml.
Recce Pharmaceuticals CEO James Graham said: “We are pleased to receive the go-ahead by the Independent Safety Committee to commence dosing of R327 at two faster infusion rates of 3,000mg.
“Results from this trial will pave the way for R327 as a potential first-line treatment for patients suffering from UTI/urosepsis.”