Disclaimer

The elements presented on this page are not an exhaustive list of information relating to the clinical trial. The inclusion and exclusion criteria have been simplified and should be interpreted by a physician. For more information please visit CTIS website for IMC-S118AI-1007.

Study design

The goal of this study is to evaluate the safety and tolerability of IMC-S118AI when administered as a single and multiple doses in participants with Type 1 Diabetes (T1D).

  • Study Type: Interventional (Clinical Trial)
  • Estimated Enrollment: 154 participants
  • Allocation:
    • Part 1: an open-label, Single Ascending Dose (SAD) study in adults – ongoing
    • Part 2: a Multiple Ascending Dose (MAD) study comprising 3 cohorts (open-label dose confirmation in adults, single-blind placebo-controlled dose expansion in adult and single-blind, placebo-controlled dose expansion in adolescents).
  • Purpose: This is a first-in-human (FIH) study designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of IMC-S118AI in single-ascending dose (SAD) and multiple-ascending dose (MAD) regimens. This study will potentially also explore the effects of multiple-dosing regimens on preservation of beta-cell function in Stage 3 Type 1 diabetes.

Criteria

Recruitment for this study is only open to people who meet these criteria.

Highlighted Inclusion:

  • Age: 12-45 years old
  • HLA type: HLA-A*02:01
  • Body mass index (BMI): 18 to 25 kg/m2
  • Confirmed diagnosis of stage 3 T1D
  • Has residual beta cell function, confirmed by blood test

Highlight Exclusion:

  • Participant has diabetes other than autoimmune T1D (type 2 diabetes, monogenic diabetes, and secondary diabetes)
  • Participant has history of recurrent hypoglycaemia due to non-compliance with insulin regimens
  • Prior treatment with immunomodulating therapy for T1D
  • Has significant cardiovascular disease or impaired cardiac function
  • Current diagnosis of a malignancy or any history of malignancy

Outcome measures

  • Incidence and severity of AEs and SAEs
  • Changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF)
  • Incidence of dose interruptions, reductions and discontinuations

Locations

Interested in more information? You can reach out directly to the site actively recruiting for this trial:

AUSTRIA

Some additional sites that are not part of the INNODIA Network may run this study too.
A complete list of participating sites can be found on CTIS website.

Sponsors and Collaborators

Immunocore