Study of IMC-S118AI in Type 1 Diabetes
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorImmunocore Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- IMC-S118AI
Treatment groups
154 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov