Study of IMC-S118AI in Type 1 Diabetes (NCT07493122) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of IMC-S118AI in Type 1 Diabetes
154 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body mass index (BMI): 18 to 25 kg/m2
* History of a diagnosis of T1D
* HLA type: HLA-A\*02:01
* Shows signs of remaining beta-cell function
Exclusion Criteria:
* Non-T1D (type 2 diabetes, monogenic diabetes, and secondary diabetes)
* History of recurrent hypoglycaemia due to non-compliance with insulin regimens
* Prior treatment with immunomodulating therapy for T1D
* Have a history of cardiovascular disease or impaired cardiac function
* Current diagnosis of a malignancy or any history of malignancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with ≥1 treatment-emergent serious adverse event (SAE)
Timeframe: Up to 60 weeks
2
Number of participants with ≥1 treatment-emergent adverse event (AE)
Timeframe: Up to 45 weeks
3
Number of participants with clinically significant changes in safety laboratory parameters
Timeframe: Up to 45 weeks
4
Number of participants with clinically significant changes in vital signs
Timeframe: Up to 45 weeks
5
Number of participants with clinically significant changes in electrocardiogram (ECG)
Timeframe: Up to 45 weeks
6
Number of participants with dose interruptions, reductions, or discontinuations