Phase 1/1B Study of IMC-S118AI in Type 1 Diabetes
Research type
Research Study
Full title
A Dose-Escalation Study Evaluating the Safety and Pharmacokinetics of IMC-S118AI in HLA-A*02:01-Positive Participants With Type 1 Diabetes
IRAS ID
1013433
Contact name
Nicola McKelvie
Contact email
Sponsor organisation
Immunocore Limited
Clinicaltrials.gov Identifier
Research summary
T1D is an autoimmune disease in which the body attacks the beta cells, these make insulin in the pancreas. People with T1D produce little/no insulin and are unable to use energy from food (like sugar). T1D is treated with insulin injections multiple times daily to manage blood sugar levels. T1D causes high blood sugar levels that can lead to health problems. Currently there is no cure for T1D. Early detection through screening allows people to learn about the disease before beta cells are destroyed and they become reliant on insulin for survival. We will test IMC-S118AI on different patient groups with T1D aged 12 to 45 who also have genetic marker (HLA-A*02:01) that is necessary for the drug to work.
In this study, IMC-S118AI will be given as a single dose or multiple doses subcutaneous or intravenous. Some participants will receive a placebo to compare the results of study participants taking IMC-S118AI. The objective of the study is to find out if the drug is safe and tolerable.
The study has 3 Parts, and participants may join Part 1 only, Part 2 only, or Part 2 plus Part 3.
Part 1: for adults 18-45 years.
Part 2: first for adults 18–45 years and after the treatment is confirmed to be, adolescents will be allowed to join the study.
Part 3: test if continuing the treatment for a longer time can preserve the beta cells longer.
Male and female participants aged 12–45 years may join the study.Interventions
Part 1: IMC-S118AI (single dose)
Part 2: IMC-S118AI or placebo (multi-dose)
Part 3: IMC-S118AI (multi-dose extension)REC name
London - Surrey Borders Research Ethics Committee
REC reference
26/LO/0101
Date of REC Opinion
3 Mar 2026
REC opinion
Further Information Favourable Opinion