Synthetic anti-infectives company Recce Pharmaceuticals (ASX:RCE) has announced it has recruited the first cohort of 10 healthy male subjects in its Phase I intravenous clinical trial of its lead compound.
The Phase I trial of RECCE 327 (R327) is an ascending dose, randomised, placebo-controlled, parallel, double-blind, single-dose study, evaluating its safety and pharmacokinetics in healthy male subjects.
The trial is being conducted at Adelaide's CMAX clinical trial facility. It will enrol a total of 80 healthy male subjects.
R327 is administered as a single dose via a one-hour intravenous infusion at a uniform rate. All 80 subjects are anticipated to have been dosed by the end of the first half of 2022.
Recce Pharmaceuticals CEO James Graham said, “We are very pleased to have the first cohort recruited for the clinical trial of R327 (IV). According to the Pew Charitable Trusts, R327 is the only clinical-stage antibiotic in the world being developed for sepsis, representing the largest unmet medical need in human health, the potential medical benefits are very significant indeed1.”
The first cohort will be dosed over two days starting 16 December 2021 with the first set of interim safety subject data expected at the end of 2021.