Type 1 DiabetesPhase 1NCT07493122
Study of IMC-S118AI in Type 1 Diabetes
A Phase 1 study testing IMC-S118AI in people with Type 1 Diabetes and Type 1 Diabetes (T1D), run by Immunocore Ltd.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 1 Diabetes, Type 1 Diabetes (T1D), Diabetes Type 1
- What is being tested?
- IMC-S118AI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Nov 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Type 1 Diabetes, Type 1 Diabetes (T1D), Diabetes Type 1
- Being tested
- IMC-S118AI
- Keywords
- diabetes, type 1
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-S118AIBiological
IMC-S118AI solution for infusion/injection
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose | Experimental | Participants receive single ascending doses of IMC-S118AI. Receives: Biological: IMC-S118AI |
| Multiple Ascending Dose | Experimental | Participants receive multiple ascending doses of IMC-S118AI. Receives: Biological: IMC-S118AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with ≥1 treatment-emergent serious adverse event (SAE)
Measured: Up to 60 weeks
Number of participants with ≥1 treatment-emergent adverse event (AE)
Measured: Up to 45 weeks
Number of participants with clinically significant changes in safety laboratory parameters
Measured: Up to 45 weeks
Number of participants with clinically significant changes in vital signs
Measured: Up to 45 weeks
Number of participants with clinically significant changes in electrocardiogram (ECG)
Measured: Up to 45 weeks
Number of participants with dose interruptions, reductions, or discontinuations
Measured: Up to 21 weeks
Secondary outcomes (3)
Plasma concentration of IMC-S118AI
Measured: Up to 21 weeks
Number of participants with anti-IMC-S118AI antibody formation
Measured: Up to 31 weeks
AUC of serum C-peptide after a 2 h MMTT at Week 25
Measured: Week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study has 2 main sequential parts: 1) single ascending dose (SAD) and 2) multiple ascending dose (MAD).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunocore Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493122
- Sponsor's protocol ID
- IMC-S118AI-1007
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07493122
- Acronym / sponsor ID
- IMC-S118AI-1007
- Conditions
- Type 1 Diabetes, Type 1 Diabetes (T1D), Diabetes Type 1
- Keywords
- diabetes, type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Immunocore LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study has 2 main sequential parts: 1) single ascending dose (SAD) and 2) multiple ascending dose (MAD).
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Biological: IMC-S118AIParticipants receive single ascending doses of IMC-S118AI. |
| Multiple Ascending Dose | Experimental | Biological: IMC-S118AIParticipants receive multiple ascending doses of IMC-S118AI. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMC-S118AIIMC-S118AI solution for infusion/injection | Biological | Multiple Ascending Dose, Single Ascending Dose |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMC-S118AI in people with Type 1 Diabetes and Type 1 Diabetes (T1D), run by Immunocore Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Immunocore Medical Information (844-466-8661, medical.information@immunocore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with ≥1 treatment-emergent serious adverse event (SAE) (time frame: Up to 60 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.