Study of IMC-S118AI in Type 1 Diabetes

March 19, 2026 updated by: Immunocore Ltd

A Dose-Escalation Study Evaluating the Safety and Pharmacokinetics of IMC-S118AI in HLA-A*02:01-Positive Participants With Type 1 Diabetes

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

154

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Ascending Dose
Participants receive single ascending doses of IMC-S118AI.
Biological: IMC-S118AI
IMC-S118AI solution for infusion/injection
Experimental: Multiple Ascending Dose
Participants receive multiple ascending doses of IMC-S118AI.
Biological: IMC-S118AI
IMC-S118AI solution for infusion/injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with ≥1 treatment-emergent serious adverse event (SAE)
Time Frame: Up to 60 weeks
Up to 60 weeks
Number of participants with ≥1 treatment-emergent adverse event (AE)
Time Frame: Up to 45 weeks
Up to 45 weeks
Number of participants with clinically significant changes in safety laboratory parameters
Time Frame: Up to 45 weeks
Up to 45 weeks
Number of participants with clinically significant changes in vital signs
Time Frame: Up to 45 weeks
Up to 45 weeks
Number of participants with clinically significant changes in electrocardiogram (ECG)
Time Frame: Up to 45 weeks
Up to 45 weeks
Number of participants with dose interruptions, reductions, or discontinuations
Time Frame: Up to 21 weeks
Up to 21 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of IMC-S118AI
Time Frame: Up to 21 weeks
Up to 21 weeks
Number of participants with anti-IMC-S118AI antibody formation
Time Frame: Up to 31 weeks
Up to 31 weeks
AUC of serum C-peptide after a 2 h MMTT at Week 25
Time Frame: Week 25
Week 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunocore Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMC-S118AI-1007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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