NCT02837094

Enhanced Epidermal Antigen Specific Immunotherapy Trial -1

Enhanced Epidermal Antigen Specific Immunotherapy Trial -1 (EE-ASI-1): A Phase 1a Study of Gold Nanoparticles Administered Intradermally by Microneedles to Deliver Immunotherapy With a Proinsulin Derived Peptide in Type 1 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Cardiff University · Academic / Other
• Sex: All
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Type 1 Diabetes is caused by the body's own white blood cells damaging the insulin producing cells in the pancreas. The aim is to develop a treatment that can slow or stop this process by switching off the white blood cells causing the damage. The aim of this study is to investigate whether giving such a treatment involving a peptide fragment related to insulin attached to gold nanoparticles is safe with no significant side-effects. Participants need to be: 1. Diagnosed with type 1 diabetes for more than 3 months. 2. Aged between 18 and 40 years. 3. Prescribed insulin within 1 month of diagnosis. Participants will have a blood test to assess whether they have the right tissue type for the study. If suitable, they will be asked to attend their local research centre for a general examination and further blood and urine tests. If the participant still has some insulin response after the post meal urine test they will proceed to the first injection. Each participant will have 3 injections of the same treatment, these are given 4 weeks apart. During the treatment, participants will undergo various monitoring including blood \& urine tests, mixed meal tolerance tests, lymph node biopsies. A follow up appointment will take place 6 weeks after the last injection. Possible side effects include bruising and discomfort at the site of the blood test and lymph node tests, local redness and swelling reactions at the site of the injections, severe allergic reaction to the injection requiring treatment, such as steroids, adrenaline or fluids. Participants will have more time with staff members to discuss their diabetes and ask questions than at a routine clinic appointment. It is not known whether receiving the gold particle-peptide injections will be of benefit, as this is the first study where the treatment is being used in humans.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	C19-A3 GNP	C19A3 GNP intradermal microinjectable solution of human C19A3 proinsulin peptide coupled to gold.

Timeline

• Start date: 2016-09-29
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2016-07-19
• Last updated: 2023-03-31

Locations

1 site across 1 country: United Kingdom