An Open-Label Study to Evaluate the Systemic Pharmacokinetics and Bioavailability of Single and Multiple Doses of RECCE®327 Topical Gel Applied to Normal Intact Skin in Healthy Male and Female Participants
Recce Pharmaceuticals LTD
12 participants
Oct 15, 2024
Interventional
Conditions
Summary
This is an open-label study to evaluate the safety/tolerability and pharmacokinetics of RECCE327 topical gel in the systemic circulation when applied to intact human skin. The study will also evaluate the safety and tolerability of RECCE327 topical gel when applied to intact human skin. All participants must meet all inclusion criteria and not meet any exclusion criteria. Study medication will be applied once daily for seven (7) days to normal intact skin. The location of the gel administration will be on the ventral mid-section of the forearm. Participants will be treated in an inpatient setting at the clinical site for 8 days, and return to the clinic for a follow-up visit on Day 14 (+/- 3 days).
Eligibility
Inclusion Criteria6
- Must be able to read and understand study information sheet and must give voluntary written informed consent prior any study assessment.
- Healthy males and females 18-55 at screening, with suitability confirmed by screening assessments.
- Female participants must: 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 [confirmed by FSH testing]), or All female participants (unless the Investigator assess them to not be of childbearing potential), must have a negative urine pregnancy test before the first dose of study medication. They must agree not to attempt to become pregnant, must not donate ova for a minimum of 30 days after the last dose of study medication, and must agree to:
- Use at least one form of highly effective contraceptive method (Appendix 22.3) between signing consent, during the study, and at least 30 days after the last dose of study medication.
- Male participants must abstain from unprotected sex and sperm donation for at least 90 days after the last dose of study medication.
- In the opinion of the investigator, the participant can undertake and complete all study procedures as outlined in the protocol.
Exclusion Criteria8
- Participants meeting any of the following criteria will be excluded from the study:
- Pregnant or breastfeeding/ lactating women.
- Clinically significant medical history, condition or illness which would preclude participation in the judgment of the Principal Investigator and/or Sponsor Medical Monitor.
- Currently suffers from clinically significant systemic allergic disease, or has a history of significant drug allergies, or risk factors for treatment adverse effects, including but not limited to: A history of anaphylactic reaction; History of type I hypersensitivity to any medication or intolerance to PEG; Known hypersensitivity to any component of the formulation of test article (RECCE®327).
- 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 medication administration.
- Clinically relevant abnormalities found in physical examination, vital signs measurements, or laboratory safety tests. e.g., skin diseases, tattoos, rashes or other abnormalities, on the dosing area.
- Has a positive result on the following at screening laboratory tests: alcohol breath test, urine test on drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV 1/2) antibodies.
- Is an immediate family member of the investigator, or is an employee of the study centre, or is in dependent relationship with a study centre’s employee who is involved in the conduct of this study or may consent under duress.
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Interventions
The study involves administering RECCE327 topical gel to normal intact skin, once daily for seven (7) days on the ventral mid-section of the forearm (area will be 4 cm x 10 cm). The daily dose amount will not exceed one tube of study medication (i.e., 4g of investigational product). The dose amount will be calculated as follows: Weight of tube before application – weight of tube after application = dose amount (g) of study medication. The safety and tolerability of the investigational product will be assessed throughout the study. Safety will be determined by physical examinations, vital signs, clinical laboratory parameters, adverse events, and skin tolerability assessments. Tolerability will be assessed with a two-part tolerability scale that incorporates dermal response and other effects of the medication on the skin.
Locations(1)
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ACTRN12624001277538