A Phase I open-label cutaneous photosensitivity study
Research type
Research Study
Full title
A Phase I open-label cutaneous photosensitivity study of MR901 in healthy volunteers
IRAS ID
194614
Contact name
Laura Cox
Contact email
Eudract number
2015-004817-26
Duration of Study in the UK
0 years, 2 months, 22 days
Research summary
The investigational medicinal product (IMP) is a light-activated, photosensitising, drug used in systemic photodynamic therapy (PDT) as a minimally invasive therapy for treating lower urinary tract symptoms (LUTS) in patients with benign prostatic hyperplasia (BPH), a condition that affects older men, is particularly common in men over 50 years of age and is not usually a serious threat to health. Patients treated with PDT display symptoms of photosensitivity which inhibits normal activities of daily living.
It is currently marketed in Japan and has been used in over 600 PDT patients.
The purpose of this investigation is to find out what happens when we expose the skin of healthy volunteers to light following intravenous infusion of the IMP. There are 2 likely patterns of cutaneous photosensitivity response: i) immediate burning sensation, erythema and transient urticaria with or without flare within 2 to 7 hours, or ii) delayed sunburn like response with erythema and tenderness within 24 hours.
The nature of the product suggests that phototoxicity to visible wavelengths of light (not ultraviolet) is likely and like the photosensitivity caused by water soluble endogenous porphyrins in certain rare porphyrin disease, an early onset (immediate up to 6 hours) response is expected.REC name
Scotland A: Adults with Incapacity only
REC reference
16/SS/0013
Date of REC Opinion
2 Feb 2016
REC opinion
Favourable Opinion