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

EU CTIS

Registry ID

CTIS2025-524449-28-00

Enrollment

Registered

2026-07-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-17

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

Conditions

Type 1 Diabetes

Brief summary

Incidence and severity of AEs, TEAEs, and SAEs, Changes in safety laboratory parameters, vital signs, and electrocardiogram, Incidence of dose interruptions, reductions, and discontinuations

Detailed description

IMC-S118AI PK parameters after single and multiple doses, Incidence of anti-IMC-S118AI antibody formation, Change from Baseline in AUC of serum C-peptide at Week 25 in participants treated with IMC-S118AI compared to placebo

Interventions

DRUG0.9% Sodium Chloride Intravenous Infusion Solution

DRUGIMC-S118AI

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Incidence and severity of AEs, TEAEs, and SAEs, Changes in safety laboratory parameters, vital signs, and electrocardiogram, Incidence of dose interruptions, reductions, and discontinuations	—

Secondary

Measure	Time frame
IMC-S118AI PK parameters after single and multiple doses, Incidence of anti-IMC-S118AI antibody formation, Change from Baseline in AUC of serum C-peptide at Week 25 in participants treated with IMC-S118AI compared to placebo	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 18, 2026