Safety and Tolerability of Single and Multiple Doses of SoftOx Biofilm Eradicator (SBE) in Chronic Leg Wounds

• Status: Completed
• Trial end date: 2022-08-19
• Target enrollment: 0
• Participant gender: All

Summary

Single-centre clinical study investigating the safety and tolerability of randomised, double-blinded, placebo-controlled ascending single doses of topically applied SoftOx Biofilm Eradicator (SBE) in patients with chronic leg wounds and of open-label once daily, twice daily, and thrice daily dosing of topically applied SBE for five days in patients with chronic leg wounds. The primary objective of the study is to assess the safety and tolerability of single and multiple doses of topically applied SBE in patients with chronic leg wounds. A secondary objective of the study is to assess changes in bacterial burden in the leg wound after treatment with SBE.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SoftOx Solutions AS

Criteria

INCLUSION CRITERIA

To be eligible for this study, patients must fulfil all of the following criteria:

1. Male and female patients aged 18 and above at time of informed consent.

2. Chronic (present for at least 4 weeks) leg wound, as judged by the Investigator, with a size of at least 1 cm2 and maximally 100 cm2 (measured as the width x length) on the day of the (first) administration of IMP.

3. Patients must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.

EXCLUSION CRITERIA

Patients are not eligible for this study if they fulfil any of the following exclusion criteria:

1. Any surgical or medical condition, including findings in the medical history or in the pre-study assessments, or any other significant disease, that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct, or evaluation at screening or time of the (first) administration of IMP.

2. Known or clinical suspicion of cancer in the leg wound at screening or time of the (first) administration of IMP, e.g., basal cell carcinoma or squamous cell carcinoma.

3. Clinical symptoms of COVID-19 or positive test for SARS-CoV-2 (testing according to local procedures) at screening or on the day of the (first) administration of IMP.

4. Clinical infection requiring systemic antibiotics at time of the (first) administration of IMP.

5. Severe ischaemia in the target leg at screening or time of the (first) administration of IMP defined as an ankle brachial index (ABI) < 0.5.

6. Necrotic tissue in leg wound at time of the (first) administration of IMP.

7. Clinically significantly reduced perception of sensation or pain assessed in proximity of the wound at screening.

8. A pain score from the leg wound above 4 assessed on a 10 cm VAS , where 0 cm indicates no pain at all and 10 cm indicates the worst imaginable pain at time of the (first) administration of IMP.

9. Use of opioids from time of screening to end of study, unless used a at stable dose, as judged by the Investigator.

10. Participation in the treatment phase of a clinical study with an investigational new drug within 30 days or 5 half-lives (whichever is longer) before the (first) administration of IMP.

11. Has previously received SBE in any of the concentrations tested in the current study.

12. Pregnant or lactating at screening or time of the (first) administration of IMP.

13. Ascertained or presumptive allergy/ hypersensitivity to any components of the IMP; history of anaphylaxis to drugs or serious allergic reactions leading to hospitalisation or any other allergy reaction in general, which the Investigator considers may affect the safety of the patient and/or outcome of the study.

14. Inability to communicate or cooperate with the Investigator (e.g., language problems, illiteracy, poor mental status) or to comply with the requirements of the study.

15. Other factors which in the opinion of the Investigator may interfere with study conduct.

16. Legal incapacity or limited legal capacity.