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NCT Number: NCT07493122

Study of IMC-S118AI in 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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes (T1D)

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMC-S118AI

Biological

IMC-S118AI solution for infusion/injection

Primary outcomes

  1. Number of participants with ≥1 treatment-emergent serious adverse event (SAE)

    Time frame: Up to 60 weeks

  2. Number of participants with ≥1 treatment-emergent adverse event (AE)

    Time frame: Up to 45 weeks

  3. Number of participants with clinically significant changes in safety laboratory parameters

    Time frame: Up to 45 weeks

  4. Number of participants with clinically significant changes in vital signs

    Time frame: Up to 45 weeks

  5. Number of participants with clinically significant changes in electrocardiogram (ECG)

    Time frame: Up to 45 weeks

  6. Number of participants with dose interruptions, reductions, or discontinuations

    Time frame: Up to 21 weeks

Secondary outcomes

  1. Plasma concentration of IMC-S118AI

    Time frame: Up to 21 weeks

  2. Number of participants with anti-IMC-S118AI antibody formation

    Time frame: Up to 31 weeks

  3. AUC of serum C-peptide after a 2 h MMTT at Week 25

    Time frame: Week 25

Study contacts

Contact information is provided by the study sponsor or research team.

Immunocore Medical Information

CONTACT

[email protected]

844-466-8661

Immunocore Medical Information EU

CONTACT

[email protected]

+00 800-744-51111

Sponsors and collaborators

Lead sponsor

Immunocore Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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