ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12624000973516

Ethics application status

Approved

Date submitted

20/06/2024

Date registered

9/08/2024

Date last updated

23/09/2026

Date data sharing statement initially provided

9/08/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

An Open-Label, Two-Part Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of RECCE®327 Topical Gel in Diabetic-Related Foot Infections: Part A – A Single-Arm Study in
DFI and ABSSSI

Scientific title

Additional trial identifiers [1]

RECCE327-G202

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Part A - Acute Bacterial Skin and Skin Structure Infection (ABSSSI) and Diabetic Foot Infections

Condition category

Condition code

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

Part A:
Part A: a multi-centre, open-label Phase 2 study. Adults with ABSSSI meeting specified
criteria will receive treatment with RECCE®327 topical gel to evaluate the potential for
systemic bioavailability and pharmacokinetics in the systemic circulation, as well as
safety, tolerability, and efficacy of single and/or multiple doses of RECCE®327 topical
gel when applied to acute bacterial skin and skin structure infections (ABSSSI),
including diabetic foot ulcer infections (DFIs) limited to skin and subcutaneous tissue.

RECCE®327 topical gel will be applied once daily at the same time each day (+/- 2
hours), in an inpatient, outpatient, or home health care setting, in addition to protocolspecified standard local wound care.

RECCE®327 topical gel application on Day 1 and Day 7 (+/- 3 days) (and Day 14 [+/- 3
days] for extended treatment) will be preceded and followed by pharmacokinetics (PK)
sample collections, to determine the concentration of RECCE®327 which may be present
in the plasma.

The initial planned treatment duration is 7 days. If, on Day 8, the response is anything
other than a cure, treatment will continue once daily until Day 14, if safe to do so. Study
medication may be stopped earlier if, in the Investigator’s judgment, this is clinically
necessary.

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.

Intervention code [1]

Treatment: Drugs

Description of the comparator or control

Part A: No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Part A: to evaluate the potential for systemic bioavailaility of singe and multiple doses of RECCE®327 topical gel applied one daily for 7 to 14 days to infected ABSSSI via analysis of plasma concentrations of RECCE®327

Timepoint [1]

Day 1: Pre-dose and 1.0 hr post-dose. Day 7 (+/- 3 days): Pre-dose; (~24 hours after the previous dose is applied) 0.5, 1.0, 2.0, and 4.0 hr post-dose (4.0 hr sample to be obtained if participant can stay in clinic). Day 14 (+/- 3 days) (extended treatment only): Pre-dose (~24 hours after the previous dose is applied) and 1.0 hr post-dose.

Primary outcome [2]

To measure the absorption of RECCE327 topical gel

Timepoint [2]

The timepoints are: - Day 1: Pre-dose and 1.0 hr post-dose. - Day 7 (+/- 3 days): Pre-dose; (~24 hours after the previous dose is applied) 0.5, 1.0, 2.0, and 4.0 hr post-dose (4.0 hr sample to be obtained if participant can stay in clinic). - Day 14 (+/- 3 days) (extended treatment only): Pre-dose (~24 hours after the previous dose is applied) and 1.0 hr post-dose.

Primary outcome [3]

To evaluate the safety/tolerability of RECCE®327 topical gel applied once daily for 7 or 14 days to infected ABSSSI.

Timepoint [3]

Baseline (Pre-dose), Day 1, Day 7, Day 14 (extended treatment participants), End of Study

Secondary outcome [1]

Part A: To evaluate the efficacy of RECCE®327 topical gel on ABSSSI by assessing the change in wound healing over time

Timepoint [1]

Lipsky Clinical Resolution of infection Scale - EOT, DFI Wound Parameters Score - Baseline, Day 7 and Day 14 (entended treatment participants only) EOT, Bates-Jensen Wound Assessment Tool (BWAT) Day 7 and Day 14 (extended treatment participant only), DFI Infection Classification: screening

Eligibility

Key inclusion criteria

- Aged 18 years or older at screening, with suitability confirmed by screening assessments.

- Wound characteristics: Part A: Presence of an ABSSSI, including DFI with IWGDF/IDSA
classification of Grade 2 (mild infection) or Grade 3 (moderate infection
limited to skin and subcutaneous tissue; no involvement of bone, tendon,
ligament, or joint) in a patient with type 1 or type 2 diabetes. An infection
with an open wound is required. An infection with an open wound is required.

- Adequate limb perfusion as defined in the protocol (e.g., at least one palpable pedal pulse in the affected limb/s in DFI).

- Body mass index (BMI) < 42

- Satisfies reproductive, contraception, and breastfeeding requirements.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

- Any diabetic-related foot ulcer (DFU) with exposed tendon, joint capsule, or
bone.

- Any DFU or adjacent structures with confirmed or strongly suspected
osteomyelitis.

- Any DFU infection that extends beyond skin and subcutaneous tissue, such as
infection involving bone, tendon, ligament, or joint tissue.

- Any DFU associated with a prosthetic device or surgical hardware at the site.

- Any DFU currently being treated with topical antimicrobial therapy that is
responding to treatment and where interruption or change of treatment is not
clinically appropriate.

- Oral antibiotics within 48 hours of study Day 1.

- Documented peripheral arterial disease with ankle brachial indices < 0.4 or toe
brachial indices < 0.5 or toe pressure < 40 mm Hg

- Known hypersensitivity to RECCE®327, polyethylene glycol (PEG), or
excipients in the investigational gel.

- Recent treatment with any investigational compound or dosing in another
clinical trial within protocol-defined windows.

- History of or current medical condition which would preclude participation in
the judgment of the Principal Investigator and Sponsor Medical Monitor.

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

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Phase 2

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

19/08/2024

Actual

19/08/2024

Date of last participant enrolment

Anticipated

1/10/2026

Actual

Date of last data collection

Anticipated

30/10/2028

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Recruitment hospital [1]

Barwon Health - Geelong Hospital campus - Geelong

Recruitment hospital [2]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

3220 - Geelong

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Recce Pharmaceuticals Limited

Address [1]

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Recce Pharmaceuticals Limited

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee A

Ethics committee address [1]

https://monashhealth.org/research/resources/resource-library/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/04/2024

Approval date [1]

18/06/2024

Ethics approval number [1]

RES-24-0000-292A

Summary

Brief summary

RECCE®327 topical gel has been developed through a stepwise clinical program from early
evaluation of safety, pharmacokinetics (PK), and preliminary efficacy to later-stage development in diabetic-related foot infection (DFI). Early clinical studies demonstrated minimal systemic absorption following topical administration, with systemic exposures substantially below those shown to be well tolerated following intravenous administration, supporting continued clinical development of RECCE®327 as a topical antibacterial therapy.
DFI has been selected as the primary target indication because of its significant unmet medical need and the potential advantages of achieving high local antimicrobial concentrations while minimizing systemic exposure. Part A of this study provided the safety, PK, and preliminary efficacy data that informed the design of Part B, a randomized, active-controlled study intended to generate comparative efficacy and safety data. Although conducted under a common protocol and governance framework, Parts A and B have separate objectives, study designs, and statistical analysis plans, and data from each part will be analysed and reported separately.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Eugene Athan

Address

Barwon Health, University Hospital Geelong, Ryrie St, Geelong, VIC 3220, Australia

Country

Australia

Phone

+61342152878

Fax

[email protected]

Contact person for public queries

Name

Julie Charlton

Address

Recce Pharmaceuticals Limited, Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102

Country

Australia

Phone

+61893629860

Fax

[email protected]

Contact person for scientific queries

Name

Julie Cahrlton

Address

Recce Pharmaceuticals, Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102

Country

Australia

Phone

+61893629860

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically