An Open-label, Phase I/Proof of Principle, Dose Escalation Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation (PCI) of Antigen/Adjuvant in Healthy Male/Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Pain as measured by Visual Analogue Scale (VAS)
研究概览
简要总结
Fimaporfin (TPCS2a) is a photosensitiser drug being developed by PCI Biotech AS for use in novel Photochemical Internalisation (PCI) technology. PCI technology is designed to enhance the effects of other drugs in a site-specific, light-directed manner and is used to re-localise endocytosed molecules from endosomes to cytosol. This research study is evaluating the use of the PCI Technology in combination with adjuvant and vaccine antigens for safety and induction of immune responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Photosensitizer and adjuvant
Run-in cohort for selection of fimaporfin starting dose in the main study. Single intradermal dosing of fimaporfin and adjuvant (Hiltonol [poly-ICLC]) followed by light application.
干预措施: Fimaporfin (Photosensitizer) (Drug)
Photosensitizer and adjuvant
Run-in cohort for selection of fimaporfin starting dose in the main study. Single intradermal dosing of fimaporfin and adjuvant (Hiltonol [poly-ICLC]) followed by light application.
干预措施: Hiltonol (Poly-ICLC) (Biological)
Photosensitizer, adjuvant and antigens
Main part: Intradermal dosing of fimaporfin, adjuvant (Hiltonol, poly-ICLC) and antigens (KLH and HPV E7) followed by light application.
干预措施: Fimaporfin (Photosensitizer) (Drug)
Photosensitizer, adjuvant and antigens
Main part: Intradermal dosing of fimaporfin, adjuvant (Hiltonol, poly-ICLC) and antigens (KLH and HPV E7) followed by light application.
干预措施: Hiltonol (Poly-ICLC) (Biological)
Photosensitizer, adjuvant and antigens
Main part: Intradermal dosing of fimaporfin, adjuvant (Hiltonol, poly-ICLC) and antigens (KLH and HPV E7) followed by light application.
干预措施: HPV E7 (Human Papilloma Virus E7) peptides (Biological)
Photosensitizer, adjuvant and antigens
Main part: Intradermal dosing of fimaporfin, adjuvant (Hiltonol, poly-ICLC) and antigens (KLH and HPV E7) followed by light application.
干预措施: KLH (Keyhole Limpet Hemocyanin) (Biological)
Assessments of time between ID dosing and light
Optional part: Assessment of different time interval between intradermal dosing of fimaporfin, adjuvant/antigens and light application.
干预措施: Fimaporfin (Photosensitizer) (Drug)
Assessments of time between ID dosing and light
Optional part: Assessment of different time interval between intradermal dosing of fimaporfin, adjuvant/antigens and light application.
干预措施: Hiltonol (Poly-ICLC) (Biological)
Assessments of time between ID dosing and light
Optional part: Assessment of different time interval between intradermal dosing of fimaporfin, adjuvant/antigens and light application.
干预措施: HPV E7 (Human Papilloma Virus E7) peptides (Biological)
Assessments of time between ID dosing and light
Optional part: Assessment of different time interval between intradermal dosing of fimaporfin, adjuvant/antigens and light application.
干预措施: KLH (Keyhole Limpet Hemocyanin) (Biological)
结局指标
主要结局
Pain as measured by Visual Analogue Scale (VAS)
时间窗: Up to 1 year
Tolerability
Incidence and grading of local skin reactions as by CTCAE v. 4.03
时间窗: Up to 1 year
Local Tolerability (pain, erythema, oedema, induration and ulceration)
Incidence of Treatment Emergent Adverse Events
时间窗: Up to 1 year
Safety
Incidence of abnormal and clinical significant measures
时间窗: Up to 1 year
Clinical Laboratory, ECG, Vital Signs and Physical Examinations
次要结局
- Induction of Immune Response(Up to 1 year)