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