RECCE®327 Topical Gel Study for the clinical indication of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
An Open-label, Pilot Efficacy Study and Exploratory Evaluation of the Systemic Bioavailability of Single and/or Multiple Doses of RECCE327 Topical Gel Applied to Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Recce Pharmaceuticals Limited
30 participants
Aug 19, 2024
Interventional
Conditions
Summary
The study is to evaluate the safety and tolerability, plasma pharmacokinetics, and efficacy of RECCE®327 topical gel when applied to Acute Bacterial Skin and Skin Structure Infections. The study will consist of sequential enrolment of up to approximately 30 participants who present with an ABSSSI, and who meet all inclusion criteria and do not meet any exclusion criteria. Participants may be treated in either the outpatient or inpatient setting. RECCE®327 topical gel will be applied once daily for seven (7) days to an ABSSSI, followed by safety and efficacy evaluations, then a possible additional seven (7) day treatment period, with repeat safety and efficacy evaluations at the end of the treatment period.
Eligibility
Plain Language Summary
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Interventions
Multi-centre, open-label study to evaluate the potential for systemic bioavailability of single and/or multiple doses of RECCE®327 topical gel into the systemic circulation when applied to acute bacterial skin and skin structure infections (ABSSSI). The study will also evaluate the safety and tolerability, plasma pharmacokinetics, and efficacy of RECCE®327 topical gel when applied to ABSSSI, after a single dose and multiple doses. The study will consist of sequential enrolment of up to approximately 30 participants who present with an ABSSSI, and who meet all inclusion criteria and do not meet any exclusion criteria. Participants may be treated in either the outpatient or inpatient setting. RECCE®327 topical gel will be applied once daily for seven (7) days to the participant's ABSSSI, followed by safety and efficacy evaluations, then a possible additional seven (7) day treatment period, (at investigator recommendation), with repeat safety and efficacy evaluations at the end of the treatment period. RECCE327 topical gel 4g single use tube. The dose amount will be calculated as follows: weight of tube before application – weight of tube after application = dose amount (g) of RECCE®327 topical gel.
Locations(2)
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ACTRN12624000973516