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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose | Experimental | Participants receive single ascending doses of IMC-S118AI. |
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| Multiple Ascending Dose | Experimental | Participants receive multiple ascending doses of IMC-S118AI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-S118AI | Biological | IMC-S118AI solution for infusion/injection |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Immunocore Medical Information | Contact | 844-466-8661 | medical.information@immunocore.com | |
| Immunocore Medical Information EU | Contact | +00 800-744-51111 | medinfo.eu@immunocore.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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The study has 2 main sequential parts: 1) single ascending dose (SAD) and 2) multiple ascending dose (MAD).
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Single blinded
| Week 25 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |