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Enhanced Epidermal Antigen Specific Immunotherapy Trial -1

NCT02837094 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-03-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

C19-A3 GNP

C19A3 GNP intradermal microinjectable solution of human C19A3 proinsulin peptide coupled to gold.

Sponsors & Collaborators

  • Cardiff University

    lead OTHER

Principal Investigators

  • Colin M Dayan, MA FRCP PhD · Cardiff University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-29
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02837094 on ClinicalTrials.gov