Recce Pharmaceuticals reveals positive safety data from phase I clinical trial of RECCE 327
Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has revealed further positive data from its phase I intravenous (IV) clinical trial of RECCE® 327 (R327), demonstrating safety and tolerability, among seven healthy male subjects in Cohort Two.
Based upon these clinical data readouts, an independent safety committee has approved a tenfold increase on the initial dosing of Cohort one (50mg) or threefold increase (from 150mg to 500mg) among 7-10 healthy subjects (Cohort Three).
Subjects are expected to be recruited this week and dosed immediately thereafter at Adelaide’s CMAX clinical trial facility.
“Successfully cleared two dosing levels”
R327 is one of the first new classes of antibiotics in over 30 years with a universal mechanism of action that allows its compounds to continuously kill bacteria and multi-drug resistant superbugs.
Recce Pharmaceuticals chief executive officer James Graham said: “We are pleased to see R327 (150mg) successfully tolerated as an intravenous infusion in Cohort Two subjects.
“Having successfully cleared two dosing levels (50mg and 150mg) we look forward to embarking upon this next significant milestone.”
Safety and tolerability demonstrated
R327 was shown to be safe and well-tolerated at the 150mg dose with no clinically significant changes in vital signs, clinical, adverse events, or laboratory parameters associated with R327.
The phase I trial is an ascending dose, randomized, placebo-controlled, parallel, double-blind, single-dose study being conducted at Adelaide’s CMAX clinical trial facility.
The study is evaluating the safety and pharmacokinetics of R327 in 7-10 healthy subjects per dose, across eight sequential dosing cohorts of 50-16,000mg.
The study is on track to have all phase I dosing complete by Q2 2022.
Story by ProactiveInvestors
Source: https://www.proactiveinvestors.com/companies/news/971396/recce-pharmaceuticals-reveals-positive-safety-data-from-phase-i-clinical-trial-of-recce-327-971396.html
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