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- Recce Pharmaceuticals (RCE) has received Human Research Ethics Committee (HREC) approval to begin its phase one intravenous (IV) trial of RECCE327 (R327)
- The phase one trial is a randomised, placebo-controlled, ascending-dose, single-dose study to evaluate the safety and pharmacokinetics of R327 in healthy males
- Roughly 80 patients will be administered a single dose, or a placebo, via a one hour IV infusion, beginning at 50 milligrams
- The first patient dose is on track for December 2021 at the CMAX clinical trial facility in Adelaide with first data expected within the calendar year
- Shares in Recce are steady on the market and are trading at 92.5 cents
Recce Pharmaceuticals (RCE) has received Human Research Ethics Committee (HREC) approval to begin its phase one intravenous (IV) trial of RECCE327 (R327).
The phase one trial is a randomised, placebo-controlled, ascending-dose, single-dose study to evaluate the safety and pharmacokinetics of R327 in healthy males.
Roughly 80 patients will be administered a single dose via a one hour IV infusion across eight groups.
Each group will have 10 patients with eight starting at 50 milligrams of R327 and two placebo.
The first patient dose is on track for December 2021 at the CMAX clinical trial facility in Adelaide with first data expected within the calendar year. The trial is expected to take around 12 months.
R327 is an intravenous (within a vein) therapy that is being developed for the treatment against serious and life-threatening infections.
Chairman Dr John Prendergast said he was excited to have received ethics approval and to begin the trial.
“Receiving human ethics approval is a momentous achievement for Recce and the clinicians seeking effective treatments to combat antibiotic-resistant bacteria,” Dr Prendergast said.
“This milestone is a significant representation of the dedication and diligence our clinical and research team put into their day-to-day work as we continue to build on our clinical and commercial potential.”
Shares in Recce were steady on the market and were trading at 92.5 cents at 1:47 pm AEDT.
