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.

QBiotics Group Limited0 个研究点目标入组 35 人开始时间: 2024年4月30日最近更新: 2024年9月9日

适应症

试验速览

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•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 48 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.

•- 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.

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