A Phase 1a, Open Label, Single Dose, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Normal Volunteers Given Punch Skin Biopsies
试验速览
- 阶段
- 1 期
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Safety and tolerability of a single dose of FGF-1 topically administered in normal volunteers given an artificial dermal wound
研究概览
简要总结
The purpose of the study is to see if FGF-1 is safe when applied topically to the surface of a wound.
详细描述
Dermal ulcers pose a significant healthcare problem in the United States, ultimately affecting 10-15% of the approximately 20 million patients with diabetes and a similar number of patients with chronic venous insufficiency. Dermal leg and foot ulcers can result from compromised arterial inflow, microvascular perfusion or venous outflow which can lead to amputation unless vascular perfusion is improved. FGF-1 for topical administration offers the possibility of improved microvascular perfusion by promoting the formation of new blood vessels in the wound bed resulting in enhanced development of granulation tissue and accelerated healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign an informed consent form prior to the initiation of any study procedures. Subjects must be competent to give written informed consent.
- •Age must be between 18 to 75 years of age.
- •Female subject must be post-menopausal or sterilized, or if she is of childbearing potential, she is not breast feeding, and her serum pregnancy test is negative.
- •Subjects must be willing to change their wound dressings daily and demonstrate to study personnel the ability to follow the dressing care instructions indicated in the Appendix. Subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. Subjects must be competent to give written informed consent.
排除标准
- •Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or chemotherapy.
- •Subjects who, at study entry, are taking systemic antibiotics.
- •Subjects who are immunosuppressed.
- •Subjects experiencing bacterial or viral infection or who may otherwise be febrile.
- •Past history or current presence of any type of cancer (except past history of basal cell carcinoma that is not on the limb being treated). Subjects with existing BCC will be excluded from the study.
- •Life expectancy of less than 1 year.
- •Active alcohol or drug abuse within 6 months prior to study entry.
- •Screening liver function tests of more than 2.0 times the upper limit of normal.
- •Serum creatinine of ≥ 2.5 mg/dl.
- •Hemoglobin A1c (HgbA1c) of >10%.
- •Exposure to any other investigational drugs or devices or participation in any other investigational studies within 30 days prior to study entry.
- •Any other medical, social, or geographical factor that would make it unlikely that the subject will comply with study procedures (e.g., alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or a history of non-compliance).
研究组 & 干预措施
Low dose
Four subjects will receive low dose FGF-1
干预措施: FGF-1 141 (Drug)
High Dose
Four subjects will receive high dose FGF-1
干预措施: FGF-1 141 (Drug)
结局指标
主要结局
Safety and tolerability of a single dose of FGF-1 topically administered in normal volunteers given an artificial dermal wound
时间窗: 1 week
次要结局
- Serum levels of FGF-1 after topical administration(1 week)