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Clinical Trial NCT07493122 for Type 1 Diabetes, Type 1 Diabetes (T1D), Diabetes Type 1 is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Study of IMC-S118AI in Type 1 Diabetes Phase 1 154 First-in-Human

Not yet recruiting
Clinical Trial NCT07493122 is designed to study Treatment for Type 1 Diabetes, Type 1 Diabetes (T1D), Diabetes Type 1. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on April 1, 2026 until the study accrues 154 participants. Led by Immunocore Ltd, this study is expected to complete by November 1, 2030. The latest data from ClinicalTrials.gov was last updated on March 25, 2026.
Brief 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.
Official Title

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

Conditions
Type 1 DiabetesType 1 Diabetes (T1D)Diabetes Type 1
Other Study IDs
  • IMC-S118AI-1007
NCT ID Number
NCT07493122
Start Date (Actual)
2026-04
Last Update Posted
2026-03-25
Completion Date (Estimated)
2030-11
Enrollment (Estimated)
154
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Keywords
diabetes
type 1
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Sequential
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSingle Ascending Dose
Participants receive single ascending doses of IMC-S118AI.
IMC-S118AI
IMC-S118AI solution for infusion/injection
ExperimentalMultiple Ascending Dose
Participants receive multiple ascending doses of IMC-S118AI.
IMC-S118AI
IMC-S118AI solution for infusion/injection
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Number of participants with ≥1 treatment-emergent serious adverse event (SAE)
Up to 60 weeks
Number of participants with ≥1 treatment-emergent adverse event (AE)
Up to 45 weeks
Number of participants with clinically significant changes in safety laboratory parameters
Up to 45 weeks
Number of participants with clinically significant changes in vital signs
Up to 45 weeks
Number of participants with clinically significant changes in electrocardiogram (ECG)
Up to 45 weeks
Number of participants with dose interruptions, reductions, or discontinuations
Up to 21 weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Plasma concentration of IMC-S118AI
Up to 21 weeks
Number of participants with anti-IMC-S118AI antibody formation
Up to 31 weeks
AUC of serum C-peptide after a 2 h MMTT at Week 25
Week 25
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Immunocore Ltd logoImmunocore Ltd10 active studies to explore
Study Central Contact
Contact: Immunocore Medical Information, 844-466-8661, [email protected]
Contact: Immunocore Medical Information EU, +00 800-744-51111, [email protected]
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