A trial to assess the safety and tolerability of EBC-1013 Gel in participants with venous leg ulcers.

This trial is designed to evaluate the safety and tolerability and to assess the systemic exposure following a single application of EBC-1013 Gel to Venous Leg Ulcers (VLUs) compared to placebo in participants with VLUs that have been present for at least one month, with size between 2.5 cm2 and 70.0 cm2. In this First in Human trial, the following 5 dose concentrations of study drug will be tested: Cohort 1: 0.1mg/g of EBC-1013 Gel Cohort 2: 0.3mg/g of EBC-1013 Gel Cohort 3: 0.6mg/g of EBC-1013 Gel Cohort 4: 1.0mg/g of EBC-1013 Gel Cohort 5: 1.5mg/g of EBC-1013 Gel. One placebo controlled (Placebo Gel without EBC-1013 active substance) blinded participant will be included into the first three dose concentration cohorts (0.1, 0.3 and 0.6 mg/g). In each of the above cohorts, EBC-1013 Gel (or placebo) will be administered at an application rate of 0.05 mL/cm2 of wound surface area. A staggered sentinel approach will be used with a 7-day waiting period after the first participant in each cohort receives EBC-1013 Gel, before expanding to dose subsequent participants. For the first three dose concentration cohorts (i.e., 0.1, 0.3, and 0.6 mg/g) an additional participant will be enrolled and dosed with Placebo Gel. For these three cohorts the first participant dosed will always receive Placebo Gel and the second participant onwards will receive EBC-1013 Gel. There is no 7-day waiting period after participants receiving Placebo Gel). For the remaining two dose concentration cohorts (1.0 and 1.5 mg/g) no participants will receive Placebo Gel. All Cohorts will be analysed together to compare dose concentrations. Once all four participants (one placebo and three active) in the first three dose concentration cohorts (i.e., 0.1, 0.3 and 0.6 mg/g) and all three participants (three active) in the last two dose concentration cohorts (1.0 and 1.5 mg/g) have received the application of EBC-1013 Gel or Placebo Gel for the current dose concentration level, and all participants in that cohort have completed their Dose Limiting Local Toxicity (DLLT) period and are deemed to be evaluable participants, the Safety Review/Dose-Escalation Committee (SRDEC) will assess safety and tolerability. If no DLLTs occurred, with the SRDEC’s approval, dose-escalation will proceed to the next dose concentration by opening recruitment to the next cohort, and this process will be repeated. If no DLLTs occur at any of the dose concentration cohorts, then an additional three active participants will be recruited at the highest drug concentration (1.5 mg/g) expanding that cohort to six to determine the best tolerated dose concentration for EBC-1013 Gel. The single dose of EBC-1013 Gel or Placebo Gel will be administered once only at the site. Application of EBC-1013 Gel or Placebo Gel will take <5 minutes. The participant will remain at the study site for post-treatment observation for at least 6 hours. They will then return to the study site for post-treatment follow-up visits on Days 1, 3, 7, 14 and 28. As this product is only applied once, by the Investigator (or delegated staff) at the site, adherence/compliance to the intervention does not need to be monitored. Prior to administration, the VLU is assessed and measured by the site who calculate the volume to be administered based on the surface area. The Medical Monitor will review and approve dose calculations. After the dose has been applied, pharmacokinetic samples will be taken periodically to assess the interventions systemic exposure over time.