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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
154
IMC-S118AI solution for infusion/injection
Number of participants with ≥1 treatment-emergent serious adverse event (SAE)
Time frame: Up to 60 weeks
Number of participants with ≥1 treatment-emergent adverse event (AE)
Time frame: Up to 45 weeks
Number of participants with clinically significant changes in safety laboratory parameters
Time frame: Up to 45 weeks
Number of participants with clinically significant changes in vital signs
Time frame: Up to 45 weeks
Number of participants with clinically significant changes in electrocardiogram (ECG)
Time frame: Up to 45 weeks
Number of participants with dose interruptions, reductions, or discontinuations
Time frame: Up to 21 weeks
Plasma concentration of IMC-S118AI
Time frame: Up to 21 weeks
Number of participants with anti-IMC-S118AI antibody formation
Time frame: Up to 31 weeks
AUC of serum C-peptide after a 2 h MMTT at Week 25
Time frame: Week 25
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