Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000544572p
Ethics application status
Submitted, not yet approved
Date submitted
26/03/2024
Date registered
30/04/2024
Date last updated
30/04/2024
Date data sharing statement initially provided
30/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to assess the safety and tolerability of EBC-1013 Gel in participants with venous leg ulcers.
Scientific title
A Phase I First-in-Human multi-centre dose escalation study to assess the safety and tolerability of EBC-1013 Gel in participants with venous leg ulcers.
Secondary ID [1] 311771 0
QB1013C-H201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Leg Ulcers 333275 0
Condition category
Condition code
Skin 329968 329968 0 0
Dermatological conditions
Skin 330114 330114 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 between three months and 24 months, with size between 5.0 cm2 and 40.0 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 each dose concentration cohort. 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 for the first two participants (one receiving EBC-1013 Gel, one receiving Placebo Gel) in each of the five dose concentration cohorts (i.e., 0.1, 0.3, 0.6, 1.0 and 1.5 mg/g).

Once all four participants (one placebo and three active) have received the application of EBC-1013 Gel or Placebo Gel for the current dose concentration level, and all four participants have completed their 7 day Dose Limiting Local Toxicity (DLLT) period, the Safety Review/Dose-Escalation Committee (SRDEC) will assess safety and tolerability of the four participants. 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. Participants from the previous cohort are not allowed to be recruited to the following cohorts.

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.
Intervention code [1] 328225 0
Treatment: Drugs
Comparator / control treatment
One placebo controlled (Placebo Gel without EBC-1013 active substance) blinded participant will be included into each of the five dose concentration cohorts.
Control group
Placebo

Outcomes
Primary outcome [1] 337730 0
To assess the overall safety and local tolerability of a single application of escalating doses of EBC-1013 Gel to Venous Leg Ulcers compared to placebo. Safety and tolerability will be assessed as a composite primary outcome.
Timepoint [1] 337730 0
Adverse event data will be collected from screening until day 28 post-treatment.

Physical examinations, vital signs, 12-lead ECGs and wound/toxicity assessments will be completed at all visits (screening, treatment day, and follow-up visits on days 1, 3, 7, 14 and 28).

Biochemistry and haematology safety assessments will be performed at Screening and follow-up visits on Days 1, 7, 14 and 28. Wound QoL 14 Questionnaire will be administered at Screening and again at the End of Study Visit on Day 28. NRS Wound Pain and Itch Scales will be completed at all visits from Screening to the End of Study Visit on Day 28.
Secondary outcome [1] 433003 0
To assess the systemic exposure resulting from a single application of escalating doses of EBC-1013 Gel.
Timepoint [1] 433003 0
PK sampling will be performed on Treatment Day as follows: pre-dose, and then at 5-mins, 15-mins, 30-mins, 1-hr, 2-hrs, 4-hrs and 6-hrs post-dose, and again at 24-hrs post-dose on Day 1
Secondary outcome [2] 433004 0
To determine the Anticipated Therapeutic Dose (ATD) or ATD range following a single application of EBC-1013 Gel when applied to Venous Leg Ulcers.
Timepoint [2] 433004 0
Assessment of DLLTs will be from the time of application (Day 0) to seven days after a single application (Day 7). The concentration(s) of EBC-1013 with less than or equal to 33% DLLTs will define the ATD or ATD range with acceptable safety and local tolerability.

Eligibility
Key inclusion criteria
- Male or female patient aged 18 years and above at screening with a Body Mass Index (BMI) of 35 or below.
- Patient with a defined Venous Leg Ulcer (VLU), which has been present for at least
three months but no longer than 24 months at Screening,
- VLU is between 5.0 cm2 and an upper limit of 40.0 cm2 at Screening
- VLU is confirmed as venous in origin by venous doppler ultrasound and an Ankle Brachial Pressure Index (ABPI) > 0.8 to < 1.3 performed at Screening.
- Oedema of the leg with the VLU is assessed by the Investigator as adequately managed with compression therapy for six weeks or more prior to Screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of non-compliance with standard of care treatment for VLU as evidenced by poorly managed leg oedema as assessed by the Investigator.
- Suspicion of current neoplastic involvement in chronicity of wound.
- Patient has an active malignancy or history of malignancy in the three years prior to screening.
- Significant hepatic or renal impairment
- Rheumatoid arthritis with known vasculitis.
- VLU has exposed tendons, ligaments, muscle or bone.
- VLU is assessed as deteriorating at Screening or has active infection requiring antibiotic treatment.
- Presence of active cellulitis on the leg with the VLU requiring antibiotic treatment.
- Debridement, skin grafts, negative pressure therapy, ultrasound therapy or systemic or topical growth factor therapy applied to the VLU within two weeks before screening.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
A conventional, rule-based 3+3 dose escalation design will be used. The planned concentrations to be investigated in five dose concentration cohorts are 0.1, 0.3, 0.6, 1.0 and 1.5 mg/g of EBC-1013 Gel at an application rate of 0.05 mL/cm2 of wound surface area. One placebo controlled blinded participant will be included into each dose concentration cohort. A staggered sentinel approach will be used with a 7-day waiting period for the first two participants (one receiving EBC-1013 Gel, one receiving Placebo Gel) in each of the five dose concentration cohorts.
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 26286 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 26287 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 42257 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 42258 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 316104 0
Commercial sector/Industry
Name [1] 316104 0
QBiotics Group Limited
Country [1] 316104 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
QBiotics Group Limited
Address
Country
Australia
Secondary sponsor category [1] 318272 0
None
Name [1] 318272 0
Address [1] 318272 0
Country [1] 318272 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314931 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 314931 0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Ethics committee country [1] 314931 0
Australia
Date submitted for ethics approval [1] 314931 0
02/04/2024
Approval date [1] 314931 0
Ethics approval number [1] 314931 0

Summary
Brief summary
The purpose of this study is to assess the safety and tolerability (how well a treatment can be tolerated by a patient) of EBC-1013 Gel. This study will be conducted in patients with Venous Leg Ulcers, aged 18 years and above.

This study will compare EBC-1013 Gel with placebo. A placebo is a medication with no active ingredients. It looks similar to the real thing, but it is not. Participants enrolled in this study will be placed into one of five different groups. Each group will receive a single treatment with one of five different dose levels of EBC-1013 Gel (0.1, 0.3, 0.6, 1.0 and 1.5 mg/g). One participant in each of the groups will receive placebo.

The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive placebo. Each group will involve a minimum of 4 participants (1 placebo and 3 active). A maximum of 7 participants will be enrolled in each cohort (1 placebo, 6 active) if any safety signals are observed in that cohort.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133174 0
A/Prof Michael Woodward
Address 133174 0
Austin Health (Heidelberg Repatriation Hospital), Medical and Cognitive Research Unit Level 3, Centaur Building 300 Waterdale Road Ivanhoe VIC 3079
Country 133174 0
Australia
Phone 133174 0
+61 3 9496 2388
Fax 133174 0
Email 133174 0
michael.woodward@austin.org.au
Contact person for public queries
Name 133175 0
Dr Marissa Lim
Address 133175 0
QBiotics Group Limited, 3A/165 Moggill Road Taringa, Queensland, 4068
Country 133175 0
Australia
Phone 133175 0
+61 7 3870 8933
Fax 133175 0
Email 133175 0
marissa.lim@qbiotics.com
Contact person for scientific queries
Name 133176 0
Dr Marissa Lim
Address 133176 0
QBiotics Group Limited, 3A/165 Moggill Road Taringa, Queensland, 4068
Country 133176 0
Australia
Phone 133176 0
+61 7 3870 8933
Fax 133176 0
Email 133176 0
marissa.lim@qbiotics.com

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.