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IMC-S118AI

Phase 1

Type 1 Diabetes | Monoclonal antibody | Metabolic |Immunocore Holdings plc|Trials Updated: Mar 25, 2026

IMC-S118AI development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2026

IMC-S118AI target and mechanism

Molecular targetPD1
Target classReceptor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment154

FDA Designations

No designations recorded

IMC-S118AI clinical trials

IMC-S118AI · 1 trial · 3 indications

Phase 1 1
NCT07493122Study of IMC-S118AI in Type 1 DiabetesType 1 Diabetes
NOT YET_RECRUITING154 Analytics
PHASE1NOT YET_RECRUITING
Study of IMC-S118AI in Type 1 Diabetes
Type 1 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Ascending DoseEXPERIMENTALParticipants receive single ascending doses of IMC-S118AI.
Multiple Ascending DoseEXPERIMENTALParticipants receive multiple ascending doses of IMC-S118AI.

Interventions

NameTypeDescription
IMC-S118AIBIOLOGICALIMC-S118AI solution for infusion/injection
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersNo

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 t...

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Frequently asked questions about IMC-S118AI

What is IMC-S118AI?

IMC-S118AI is an investigational monoclonal antibody being developed by Immunocore Holdings plc for the treatment of Type 1 Diabetes. It is in Phase 1 clinical development and is a biomarker-selected therapy, meaning trial enrollment is guided by a specific biological marker. It has not been approved by the FDA.

What is IMC-S118AI used for in Type 1 Diabetes?

IMC-S118AI is being studied as a treatment for Type 1 Diabetes in adults 18 years and older. The Phase 1 program is designed to evaluate the drug in this metabolic indication. It remains investigational and is not approved for any use.

What does IMC-S118AI target?

IMC-S118AI targets PD1, also known as programmed cell death protein 1, which is a receptor. By binding to this receptor, the monoclonal antibody is designed to act on PD1-mediated signaling pathways. PD1 is the molecular target of the investigational therapy.

Who is developing IMC-S118AI?

IMC-S118AI is being developed by Immunocore Holdings plc, which trades on the Nasdaq under the ticker IMCR. The company is the sponsor of the clinical program evaluating the drug in Type 1 Diabetes.

What phase is IMC-S118AI in?

IMC-S118AI is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA. The Phase 1 program is currently active, with one trial listed and no completed trials.

What clinical trials is IMC-S118AI in?

IMC-S118AI is being evaluated in the Phase 1 study NCT07493122, titled Study of IMC-S118AI in Type 1 Diabetes. The trial is not yet recruiting, is controlled and randomized, and plans to enroll 154 participants aged 18 years and older.