Status and phase
Conditions
Treatments
About
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.
Full 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:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Clinical diagnosis of type 1 diabetes for > 3 months (dated from the first insulin injection).
Commenced on insulin treatment within 1 month of diagnosis.
Age 16 to 40 years
2 hour post-meal UCPCR > 0.53 nmol/mmol on at least one occasion (maximum 3 tests on different days)
Possession of 0401 allele at the HLA-DRB1 gene locus
The following birth control methods should be used (considered highly effective with a failure rate of less than 1% per year when used consistently and correctly]:
combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
progestogen-only hormonal contraception associated with inhibition of ovulation:
intrauterine device (IUD)
intrauterine hormone-releasing system (IUS)
bilateral tubal occlusion
vasectomised partner (provided that the partner is the sole sexual partner of the trial participant and that medical assessment of azoospermia has been confirmed)
Sexual abstinence (defined as refraining from hetrosexual intercourse during the duration of the trial)
Written and witnessed informed consent to participate.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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