Health TrialsbyHealthPanel

Study of IMC-S118AI in Type 1 Diabetes

ConditionsType 1 DiabetesType 1 Diabetes (T1D)Diabetes Type 1
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorImmunocore Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • IMC-S118AI

    Biological/Vaccine

    IMC-S118AI solution for infusion/injection

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: Single Ascending DoseExperimental treatment 1 intervention
Group B: Multiple Ascending DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with ≥1 treatment-emergent serious adverse event (SAE)

Time frame
Up to 60 weeks
2

Number of participants with ≥1 treatment-emergent adverse event (AE)

Time frame
Up to 45 weeks
3

Number of participants with clinically significant changes in safety laboratory parameters

Time frame
Up to 45 weeks
4

Number of participants with clinically significant changes in vital signs

Time frame
Up to 45 weeks

Secondary outcomes

1

Plasma concentration of IMC-S118AI

Time frame
Up to 21 weeks
2

Number of participants with anti-IMC-S118AI antibody formation

Time frame
Up to 31 weeks
3

AUC of serum C-peptide after a 2 h MMTT at Week 25

Time frame
Week 25

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immunocore Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: