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
Inclusion Criteria5
- Must be able to read and understand study information sheet and must give voluntary written informed consent prior any study assessment
- Aged 18 years or older at screening, with suitability confirmed by screening assessments.
- Female participants must: a) Be of non-child-bearing potential or surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the Screening Visit) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or b) All female participants (unless the Investigator assesses them to not be of childbearing potential), must have a negative urine pregnancy test before the first RECCE®327 administration (Day 1). They must agree not to attempt to become pregnant, must not donate ova for a minimum of 30 days after last RECCE®327 administration, and must agree to: Use at least one form of highly effective contraceptive method between signing consent, during the study, and at least 30 days after the last dose of study therapy.
- Male participants must agree to abstain from unprotected sex and sperm donation after signing the consent through 90 days after the last dose of study medication.
- Presence of an ABSSSI. For DFI an infection with an open wound is required (Diabetic Foot Ulcer Scale - Grade 1)
Exclusion Criteria5
- Currently pregnant or breastfeeding/lactating women.
- History of current clinically significant medical history or condition which would preclude participation in the judgment of the Principal Investigator and Sponsor Chief Medical Officer.
- Use of any investigational compound, or dosing in another clinical trial within 30 days or 5 half-lives of the investigational product, whichever is longer, prior to the planned first study drug administration.
- Wounds with exposed tendons or exposed bone.
- Participant is unable to perform wound dressings and administer IP as per protocol, or lacks support person (i.e., home health care) to perform this function.
Interested in this trial?
Get notified about updates and connect with the research team.
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)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12624000973516