Study of IMC-S118AI in Type 1 Diabetes

Sponsor
Immunocore Ltd
Study ID
NCT07493122
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • IMC-S118AI — BIOLOGICAL
    IMC-S118AI solution for infusion/injection

Study Details

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.

Key Dates

First listed
Mar 25, 2026
Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Nov 30, 2030
Completion
Nov 30, 2030

Study Design

Enrollment
154 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single Ascending Dose
    Participants receive single ascending doses of IMC-S118AI.
  • Experimental: Multiple Ascending Dose
    Participants receive multiple ascending doses of IMC-S118AI.

Primary Outcome Measure

Number of participants with ≥1 treatment-emergent serious adverse event (SAE) [ Time Frame: Up to 60 weeks ]

Central Contacts

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