Recce Pharmaceuticals has completed dosing of healthy male and female subjects in a Phase I/II clinical trial of RECCE 327 (R327) to treat urinary tract infections (UTIs).
The open label, crossover study is designed to assess the pharmacodynamics, safety, and pharmacokinetics (PK) of RECCE 327.
Healthy males and females aged 18 to 65 years will receive a 2000mg–3000mg dose of RECCE 327 at infusion rates ranging from 15 to 45 minutes.
The study includes up to four cohorts with four participants at each dose level.
Initially, each participant will be given RECCE327 as a single dose intravenously over Period A, followed by 48 hours of safety surveillance and PK data collection.
With a minimum time elapsed of 48 hours, the second dose of RECCE 327 will be infused over Period B with the same dose level and dose concentration.
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A non-Data Safety Monitoring Board committee will review the safety and PK data for the subsequent cohort.
It may suggest an adjustment of the dose level, infusion rate or concentration of RECCE 327 before advancing to the next cohort.
The study’s primary outcome is to assess the safety, tolerability and PK of RECCE 327 while the secondary outcome is to evaluate its concentration in urine at different doses and infusion rates.
Evaluating ex vivo pharmacodynamics of urine and blood from healthy male and female volunteers is the other secondary outcome of the study.
Recce Pharmaceuticals CEO James Graham said: “We are pleased to see R327 administered at a faster infusion rate of 3,000mg, reinforcing R327’s safety profile among male and female subjects.
“These results further support R327’s potential as a treatment option for patients with UTIs, which, if left untreated, could result in urosepsis.
“Today, urosepsis accounts for approximately 30% of all sepsis infections and significantly impacts both patients and the healthcare industry.”