Study of IMC-S118AI in Type 1 Diabetes

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07493122

Enrollment

154

Registered

2026-03-25

Start date

2026-04-01

Completion date

2030-11-01

Last updated

2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 1, Type 1 Diabetes, Type 1 Diabetes (T1D)

Keywords

diabetes, type 1

Brief summary

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.

Interventions

BIOLOGICALIMC-S118AI

IMC-S118AI solution for infusion/injection

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Single blinded

Intervention model description

The study has 2 main sequential parts: 1) single ascending dose (SAD) and 2) multiple ascending dose (MAD).

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Plasma concentration of IMC-S118AI	Up to 21 weeks
Number of participants with anti-IMC-S118AI antibody formation	Up to 31 weeks
AUC of serum C-peptide after a 2 h MMTT at Week 25	Week 25

Contacts

CONTACTImmunocore Medical Information

medical.information@immunocore.com844-466-8661

CONTACTImmunocore Medical Information EU

medinfo.eu@immunocore.com+00 800-744-51111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026