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Not yet recruiting NCT07493122

Study of IMC-S118AI in Type 1 Diabetes

Phase I Interventional Type 1 Diabetes Type 1 Diabetes (T1D) Diabetes Type 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IMC-S118AI.
Who it may be relevant to
Registry conditions: Type 1 Diabetes, Type 1 Diabetes (T1D), Diabetes Type 1. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Biological IMC-S118AI
    IMC-S118AI solution for infusion/injection

Primary outcome measures

  • Number of participants with ≥1 treatment-emergent serious adverse event (SAE) [Time frame: Up to 60 weeks]
  • Number of participants with ≥1 treatment-emergent adverse event (AE) [Time frame: Up to 45 weeks]
  • Number of participants with clinically significant changes in safety laboratory parameters [Time frame: Up to 45 weeks]
  • Number of participants with clinically significant changes in vital signs [Time frame: Up to 45 weeks]
  • Number of participants with clinically significant changes in electrocardiogram (ECG) [Time frame: Up to 45 weeks]
  • Number of participants with dose interruptions, reductions, or discontinuations [Time frame: Up to 21 weeks]
Secondary outcome measures (3)
  • Plasma concentration of IMC-S118AI [Time frame: Up to 21 weeks]
  • Number of participants with anti-IMC-S118AI antibody formation [Time frame: Up to 31 weeks]
  • AUC of serum C-peptide after a 2 h MMTT at Week 25 [Time frame: Week 25]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07493122 · IMC-S118AI-1007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗