Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
Status:
Unknown status
Trial end date:
2020-01-31
Target enrollment:
Participant gender:
Summary
The study is a two centre, open-label, uncontrolled single group phase 1A study of C19-A3 GNP
peptide (10 μg peptide equivalent content) administered via Nanopass microneedles every 28
days for 8 weeks (3 doses), with follow-up for 6 weeks (14 weeks in total from first dose).
Treatment will be given into the arm at a volume of 50ul.
No blinding or randomisation will be performed. In keeping with standard phase 1 study
designs, no placebo or control group is included as the primary aim is to establish whether
there are any major unexpected safety issues in the use of this IMP for the first time in
man. 8 subjects will be recruited at 2 centres: Cardiff, UK and Linköping, Sweden.