Study of IMC-S118AI in Type 1 Diabetes

Immunocore

Status and phase: Not yet enrolling; Phase 1

Conditions: Type 1 Diabetes (T1D); Type 1 Diabetes; Diabetes Type 1

Treatments: Biological: IMC-S118AI

Study type: Interventional

Funder types: Industry

Identifiers

NCT07493122

IMC-S118AI-1007

Details and patient eligibility

About

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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 to non-compliance with insulin regimens
• Prior treatment with immunomodulating therapy for T1D
• Have a history of cardiovascular disease or impaired cardiac function
• Current diagnosis of a malignancy or any history of malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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154 participants in 2 patient groups

Single Ascending Dose

Experimental group

Description:

Participants receive single ascending doses of IMC-S118AI.

Treatment:

Biological: IMC-S118AI

Multiple Ascending Dose

Experimental group

Description:

Participants receive multiple ascending doses of IMC-S118AI.

Treatment:

Biological: IMC-S118AI