NCT07493122Not yet recruitingPhase 1
Study of IMC-S118AI in Type 1 Diabetes
A Dose-Escalation Study Evaluating the Safety and Pharmacokinetics of IMC-S118AI in HLA-A*02:01-Positive Participants With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 154 (estimated)
- First submitted
- 19 Mar 2026
- Start date
- Apr 2026
- Primary completion date
- Nov 2030
- Lead sponsor
- Immunocore Ltd
- Diseases
- Type 1 diabetes
- NCT number
- NCT07493122
- EU CT number
- 2025-524449-28-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 154
- From Apr 2026 to the primary completion date, Nov 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with immunomodulating therapy for T1D
Other illness
- Non-T1D (type 2 diabetes, monogenic diabetes, and secondary diabetes)
- History of recurrent hypoglycaemia due to non-compliance with insulin regimens
- Have a history of cardiovascular disease or impaired cardiac function
- Current diagnosis of a malignancy or any history of malignancy
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.