RECCE®327 Topical Gel Study for the clinical indication of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
- Conditions
- Acute Bacterial Skin and Skin Structure Infection (ABSSSI)Infection - Studies of infection and infectious agents
- Registration Number
- ACTRN12624000973516
- Lead Sponsor
- Recce Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
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)
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method