Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001277538
Ethics application status
Approved
Date submitted
18/09/2024
Date registered
18/10/2024
Date last updated
18/10/2024
Date data sharing statement initially provided
18/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 312979 0
RECCE327-G103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Bacterial Skin and Skin Structure Infections 335160 0
Diabetic Foot Infections 335161 0
Condition category
Condition code
Infection 331657 331657 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 329517 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339384 0
To evaluate the pharmacokinetics and systemic bioavailability of single and multiple doses of RECCE327 topical gel applied once daily for 7 days to normal intact skin in healthy male and female participants via analysis of plasma and urine concentrations of RECCE327 (Oligomer 4 and Oligomer 5). Composite outcome.
Timepoint [1] 339384 0
Day 1: pre-dose, 1, 2, 4, 8, 12, 24 (Day 2), Da y 3, Day 4, Day 5, Day 6: pre-dose (trough), Day 7: pre-dose, 1, 2, 4, 8, 12 24 (Day 8)
Primary outcome [2] 339478 0
To evaluate the safety/tolerability of RECCE®327 topical gel applied once daily for 7 days to normal intact skin in healthy male and female participants.
Timepoint [2] 339478 0
Screening, Baseline, Day 1-8, and Day 14
Secondary outcome [1] 439770 0
To evaluate the concentration of RECCE327 in urine at different doses.
Timepoint [1] 439770 0
Day 1: Pre-dose, 0-4, 4-8, 8-12, 12-24 (24 timepoint is Day 2), Day 7: Pre-dose, 0-4, 4-8, 8-12, 12-24 (24 timepoint is Day 8),

Eligibility
Key inclusion criteria
All participants are required to meet all the following inclusion criteria:
- 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/10/2024
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
12
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27110 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 43188 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 317419 0
Commercial sector/Industry
Name [1] 317419 0
Recce Pharmaceuticals LTD
Country [1] 317419 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Recce Pharmaceuticals LTD
Address
Country
Australia
Secondary sponsor category [1] 319703 0
None
Name [1] 319703 0
Address [1] 319703 0
Country [1] 319703 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316141 0
Bellberry Human Research Ethics Committee D
Ethics committee address [1] 316141 0
Ethics committee country [1] 316141 0
Australia
Date submitted for ethics approval [1] 316141 0
02/08/2024
Approval date [1] 316141 0
18/09/2024
Ethics approval number [1] 316141 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136914 0
Dr Christopher Argent
Address 136914 0
Scientia Clinical Research, The Bright Building, Level 5, Corner High & Avoca Streets, Randwick NSW 2031
Country 136914 0
Australia
Phone 136914 0
+61 293825800
Fax 136914 0
Email 136914 0
[email protected]
Contact person for public queries
Name 136915 0
Julie Charlton
Address 136915 0
Recce Pharmaceuticals Limited, Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102
Country 136915 0
Australia
Phone 136915 0
+610893629860
Fax 136915 0
Email 136915 0
[email protected]
Contact person for scientific queries
Name 136916 0
Julie Charlton
Address 136916 0
Recce Pharmaceuticals, Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102
Country 136916 0
Australia
Phone 136916 0
+610893629860
Fax 136916 0
Email 136916 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.