A Phase 1, Open-Label Clinical Trial to Assess the Safety, Tolerability, and Preliminary Efficacy Study of a Single Dose of Topically Administered LUT017 Gel for Cutaneous Wound Healing in Volunteers With Healthy Skin
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a Phase 1 research study evaluating the safety and potential benefits of a topical gel called LUT017 in helping skin wounds heal after minor skin procedures. The study will enroll healthy adults who are already scheduled to have two benign (non-cancerous) skin lesions, such as moles, removed as part of routine care.
When the lesions are removed, two small wounds will be created. One wound will be treated with LUT017 gel, and the other will be treated with a placebo gel that does not contain active medication. This allows each participant to serve as their own comparison. The study team will monitor how the wounds heal over approximately one week using clinical evaluation, photographs, and safety assessments.
LUT017 is a topical medication designed to activate natural skin repair pathways and potentially promote faster healing. The main purpose of this study is to determine whether a single application of LUT017 gel is safe and well tolerated when applied to fresh skin wounds, and to look for early signs that it may improve or speed up wound healing compared to placebo.
The primary question this study aims to answer is: Is LUT017 gel safe when applied to acute skin wounds, and does it show preliminary evidence of improving early wound healing in healthy adults?
Participants will be followed for about one week after treatment, with blood tests and skin evaluations to monitor for any side effects. The information gathered from this study will help determine whether LUT017 should continue to be developed as a potential treatment to support wound healing.
详细描述
Study Overview and Clinical Context
This is a Phase 1, open-label, ascending-dose clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary biological activity of LUT017 gel when applied topically to acute, procedure-generated cutaneous wounds in healthy adult subjects. The study represents the first clinical investigation of LUT017 in the setting of acute wound healing in normal skin and is intended to establish an initial safety profile, characterize systemic exposure following single-dose topical administration, and inform dose selection for future controlled trials in impaired wound-healing conditions.
Participants are healthy adults who are already scheduled to undergo elective excision of two or more clinically benign skin lesions. These procedures create standardized acute wounds, allowing controlled evaluation of early healing responses under reproducible conditions. The study uses a paired-wound intra-subject comparison design, in which one wound receives LUT017 gel and the other receives placebo. This approach minimizes inter-subject variability and enhances the interpretability of early biological effects.
The therapeutic hypothesis underlying this study is that localized activation of epidermal regenerative signaling pathways can enhance early re-epithelialization and wound repair without inducing clinically significant systemic exposure or proliferative toxicity.
Mechanistic Rationale
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects scheduled to undergo excision of two or more clinically benign skin lesions (e.g., melanocytic nevi or seborrheic keratoses) that will result in at least two comparable acute cutaneous wounds suitable for study treatment.
- •Subject must be ≥ 18 years of age.
- •Subjects must be in generally good health, with no dermatologic or systemic condition that may impair normal wound healing, as determined by the Investigator.
- •Lesions selected for excision must be benign, confirmed clinically by the treating dermatologist or surgeon prior to the procedure.
- •Must be able and willing to provide informed consent prior to study participation.
- •Female subjects of childbearing potential must have a negative pregnancy test at day
- •They should agree to use highly effective methods of birth control, defined as those with failure less than 1%, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUD's), sexual abstinence, or a vasectomized partner.
排除标准
- •Any lesion scheduled for excision that is suspicious for malignancy or has not been clinically assessed as benign by the treating dermatologist or surgeon.
- •History of abnormal wound healing, including keloid formation, hypertrophic scarring, chronic non-healing wounds, or delayed healing after prior procedures.
- •Target ulcer shows any signs of infection (only non-infected ulcers are eligible).
- •Unable to tolerate multi-layer bandages or compression garments.
- •Decompensated congestive heart failure.
- •Active soft tissue or bone infection requiring antibiotics.
- •Skin cancer on the target limb within the last 24 months.
- •Actively receiving chemotherapy and/or radiation therapy for cancer.
- •Treatment with a serine/threonine-protein kinase BRAF inhibitor, including but not limited to Zelboraf® (vemurafenib), Tafinlar® (dabrafenib), BraftoviTM (encorafenib) or Nexavar® (sorafenib), within 30 days or 5 half-lives of the drug prior to Day 0, whichever is longer.
- •Blood chemistry and complete blood count (CBC) values from the most recent laboratory assessment performed within the past 12 monsth:
- •White Blood Cells (WBC) < 1.5 x 109/L.
- •Absolute < 0.9 x 109/L.
- •Platelet count < 50 x 109/L.
- •Alanine aminotransferase > 3 x upper limit of normal.
- •Aspartate aminotransferase > 3 x upper limit of normal.
- •Serum albumin <2.0 g/dL.
- •Current use of systemic corticosteroids > 5 mg daily or equivalent within 4 weeks.
- •Currently pregnant or trying to become pregnant.
- •Inability or unwillingness to participate in all aspects of study protocol or as determined by the Investigator.
- •Known hypersensitivity to the ingredients of the study drug.
- •No known history of diabetis
研究组 & 干预措施
UT017 Gel 0.03%
Subjects receive a single topical application of LUT017 gel 0.03% to one acute excisional wound and placebo gel to a paired wound immediately following benign lesion removal. Safety, tolerability, pharmacokinetics, and early wound healing are assessed over 7 days.
干预措施: LUT017,Topical BRAF inhibitor (Drug)
LUT017 Gel 0.1%
Subjects receive a single topical application of LUT017 gel 0.1% to one acute excisional wound and placebo gel to a paired wound immediately following benign lesion removal. Safety, tolerability, pharmacokinetics, and early wound healing are assessed over 7 days.
干预措施: LUT017,Topical BRAF inhibitor (Drug)
LUT017 Gel 0.25%
Subjects receive a single topical application of LUT017 gel 0.25% to one acute excisional wound and placebo gel to a paired wound immediately following benign lesion removal. Safety, tolerability, pharmacokinetics, and early wound healing are assessed over 7 days.
干预措施: LUT017,Topical BRAF inhibitor (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: From Day 0 (study drug administration) through Day 7 follow-up visit (±2 days)
Safety and tolerability of a single topical application of LUT017 gel assessed by the number and severity of treatment-emergent adverse events, including local cutaneous reactions, systemic adverse events, clinically significant laboratory abnormalities, and investigator-assessed relatedness to study drug.
次要结局
- Investigator-Assessed Early Wound Healing Progression(Day 7 (±2 days) after study drug administration)
- Standardized Photographic Documentation of Wound Healing(Day 7 (±2 days) after study drug administration)
- Investigator Determination of LUT017 Re-application(Day 7 (±2 days) after study drug administration)
研究者
Antoni Ribas
Professor of medicine, surgery, and molecular and medical pharmacology at UCLA
University of California, Los Angeles