Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Safety and Pharmacokinetic Dose-Escalation Study of IMC-S118AI and Sodium Chloride in HLA‑A*02:01‑Positive Participants with Type 1 Diabetes

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at individuals who have Type 1 Diabetes, a condition in which the body stops producing insulin, the hormone needed to control blood sugar. The investigational medication being tested is called IMC‑S118AI and is given by an IV infusion, which means it is delivered directly into a vein. A standard salt‑water solution (sodium chloride) is used as a comparison in the trial.

The purpose of the study is to evaluate the safety and how the drug behaves in the body. Participants receive a single dose of either the study drug or the comparison solution, followed by several additional doses over a number of weeks. During this time, regular check‑ups, blood tests, and heart rhythm recordings (electrocardiogram) are performed to watch for side effects and to measure drug levels. The trial also examines whether the treatment changes the amount of a protein called C‑peptide, which reflects the pancreas’s remaining ability to produce insulin.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Screening and baseline assessments

    After you join the study, you will undergo a series of tests to confirm that you meet the study requirements. these tests include blood samples, measurements of vital signs such as blood pressure and heart rate, and an electrocardiogram (ecg) to record the electrical activity of the heart.

    The results create a baseline record that will be used to compare any changes that occur during the study.

  2. Step 2

    Randomization and first intravenous infusion (single dose)

    Once baseline data are collected, you will be assigned to receive either the investigational medicine imc-s118ai or the placebo 0.9% sodium chloride solution. the assignment is made by the study system and you will not know which you receive.

    The assigned product will be given as an intravenous infusion, meaning it is delivered directly into a vein through a small tube. this first infusion is a single dose administered on the day of randomization.

  3. Step 3

    Short‑term safety monitoring after the single dose

    Following the infusion, you will be observed for a period of time while medical staff check for any immediate reactions. this includes repeat measurements of vital signs, additional blood tests, and another ecg if needed.

    Any side effects or changes are recorded as part of the study’s safety evaluation.

  4. Step 4

    Multiple‑dose phase

    If you continue in the study, you will receive additional infusions of the same product (either imc-s118ai or 0.9% sodium chloride) according to the study schedule. the exact frequency and total number of doses are defined by the study protocol, but each dose is administered intravenously under medical supervision.

    The purpose of the multiple‑dose phase is to evaluate how the medication behaves in the body over several administrations and to monitor safety over a longer period.

  5. Step 5

    Ongoing safety and laboratory evaluations

    Throughout the multiple‑dose period, you will have regular visits for safety checks. these visits include blood sampling, vital‑sign measurements, and ecg recordings to detect any changes.

    The study team will also look for the development of antibodies against imc-s118ai, which could affect how the body responds to the medication.

  6. Step 6

    Week 25 assessment of c‑peptide response

    Approximately 25 weeks after the start of treatment, a specific blood test will be performed to measure the area under the curve (auc) of serum c‑peptide. c‑peptide is a marker of insulin production, and this measurement helps determine whether the medication has an effect on pancreatic function compared with placebo.

  7. Step 7

    Final study visit and follow‑up

    At the end of the study, you will attend a final visit where all remaining safety data are collected, including final laboratory tests and vital‑sign recordings.

    After this visit, the study concludes for you, and any further follow‑up will be arranged according to the study’s long‑term safety plan.

Who can join the trial?

6 criteria

  • Age must be between 12 and 45 years.
  • Both male and female participants are allowed.
  • You need to have a specific genetic marker called HLA‑A*02:01 (a type of tissue‑matching protein that helps the immune system recognize cells).
  • Your body mass index (BMI) must be between 18 and 25 kg/m² (BMI is a simple calculation using height and weight to estimate body size).
  • You must have a history of being diagnosed with Type 1 Diabetes (a condition where the body no longer makes enough insulin).
  • You should show signs that your pancreas still has some working beta‑cell function (beta cells are the cells that normally produce insulin).

Who cannot join the trial?

5 criteria

  • Not having Type 1 Diabetes – this includes people who have Type 2 diabetes, a rare single‑gene form of diabetes (monogenic diabetes), or diabetes caused by another condition (secondary diabetes).
  • History of frequent low blood‑sugar episodes because of not following the insulin plan – low blood sugar is called hypoglycaemia.
  • Previously received medicines that change the immune system for Type 1 Diabetes – these are called immunomodulating therapies.
  • Having heart disease or a weak heart – this means any past or present cardiovascular disease or reduced ability of the heart to pump blood (impaired cardiac function).
  • Having cancer now or ever having had cancer – cancer is also known as a malignancy.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

IMC-S118AI is an experimental medication being studied to see if it is safe and well‑tolerated in people who have type 1 diabetes and carry a specific genetic marker (HLA‑A*02:01). In this trial, participants receive the drug by injection into a vein, first as a single dose and later as several doses over time. Researchers will watch for any side effects and will measure how the drug moves through the body (its pharmacokinetics) to understand how it is absorbed, distributed, and cleared. This information helps determine whether the medication might be useful for treating type 1 diabetes in the future.

What is already known about the treatment

  • 0.9% Sodium Chloride Intravenous Infusion Solution

    This medication is given by slow IV infusion of a clear sterile solution. It is an established, widely used product that serves as a fluid and electrolyte replacement in hospitals. It is mainly used to restore water and salt balance when patients are dehydrated or need extra fluid during surgery. At the molecular level it simply adds sodium and chloride ions to the blood, and it is classified as an isotonic crystalloid solution.

  • IMC‑S118AI

    This drug is administered by a single‑dose or multiple‑dose IV injection of a clear solution for injection. It is an investigational agent that is currently being studied in clinical trials and is not yet approved for routine medical use. The trial is testing it as a possible treatment for type 1 diabetes, aiming to modify the immune response that attacks the pancreas. Its exact way of working is still being researched, but it is being developed as an experimental immunomodulatory therapy.

Investigated diseases

Type 1 Diabetes - Type 1 Diabetes is a condition where the pancreas stops making enough insulin, a hormone that helps control blood sugar. It usually begins in childhood or early adulthood, but can appear at any age. Without enough insulin, blood sugar levels rise gradually, leading to increased thirst, frequent urination, and tiredness. Over time, the body may use more fat for energy, causing weight loss. The disease progresses as the immune system continues to damage the insulin‑producing cells, reducing insulin supply further.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-524449-28-00Protocol codeIMC-S118AI-1007Estimated enrolment154 patientsSponsorImmunocore Limited

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.