Trial IDACTRN12623000448640Date registered02 May 2023Health...

Trial IDACTRN12623000448640Date registered02 May 2023Health conditionLife threatening infectious disease, Urinary Tract InfectionRecruitment countriesAustraliaRecruitment site location(s) (State)New South Wales, South AustraliaRecruitment statusRecruitingAnticipated date of first participant enrolment29 May 2023Ethics application statusApprovedBrief summarySingle centre, adaptive design, open-label, two period crossover, study to evaluate the safety, pharmacokinetics and ex vivo antibacterial effects of RECCE®327 in healthy male and female volunteers.This study consists up to 4 cohorts with 4 participants at each dose level. The first cohort will involve two infusion rates 45 minutes (Period A) and 30 minutes (Period B) of RECCE®327 at a concentration of 4 mg/ml. Each participant will begin with a single dose with RECCE®327 intravenously over 45 minutes, followed by 48 hours safety surveillance and PK data collection. Safety assessments will be performed by the investigational site study staff and reviewed (sign off) by the PI or designee before the second dose of RECCE®327 infusion over 30 minutes with the same dose level and dose concentration and with a minimum time elapsed of 48 hours from the start of the first dose to the second dose.For the subsequent cohort, a non-DSMB committee will review the safety and PK data (latter if available), and may suggest an adjustment of dose level, infusion rate and / or concentration of the RECCE®327 before proceeding to the next cohort. The non-DSMB committee may determine not to proceed with additional cohorts as well.the aim of this study is to investigate possible safety dose of RECCE®327 in various dose levels and infusion duration.