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

Condition studied

Type 1 Diabetes

Investigational medicinal product(s)

Eligibility

Primary endpoint

Incidence and severity of AEs, TEAEs, and SAEs, Changes in safety laboratory parameters, vital signs, and electrocardiogram, Incidence of dose interruptions, reductions, and discontinuations

Endpoint detail

IMC-S118AI PK parameters after single and multiple doses, Incidence of anti-IMC-S118AI antibody formation, Change from Baseline in AUC of serum C-peptide at Week 25 in participants treated with IMC-S118AI compared to placebo