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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Graz	Graz	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	01.08.2026

Trial locations

Investigated Drugs:

Sodium Chloride

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.

Investigated Diseases:

Type 1 diabetes mellitus

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 ID:

2025-524449-28-00

Protocol code:

IMC-S118AI-1007

NCT ID:

NCT07493122

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?