In short
IMC S118AI is an investigational drug being studied in type 1 diabetes. It is given intravenously, and the first clinical trial is a Phase 1/1b study that has been authorised. The trial plans to enrol 154 participants and will look mainly at safety and tolerability.
Key points
- IMC S118AI is an investigational substance studied in type 1 diabetes.
- The only registered trial is a Phase 1/1b study with 154 planned participants.
- The trial is currently authorised, which means it has been approved but is not yet recruiting.
- IMC S118AI is given by intravenous infusion.
- The primary goal is to measure safety and tolerability, including side effects and laboratory changes.
What is IMC S118AI?
IMC S118AI is an investigational drug. This means it is not yet approved as a medicine. The only registered clinical trial is a Phase 1/1b study in type 1 diabetes. No other names or development codes are given in the registry data. No marketing authorisation is recorded for this substance.
How does IMC S118AI work?
The registry record does not describe the mechanism of action of IMC S118AI. The trial brief summary states only that the study will evaluate safety and tolerability when the drug is given as single and multiple doses to participants with type 1 diabetes. No molecular target or pharmacological class is provided in the available data.
Which conditions is IMC S118AI studied for?
- Type 1 diabetes — a condition in which the body cannot make enough insulin. The registered trial is testing IMC S118AI in people with this condition.
How is IMC S118AI given?
IMC S118AI is given by intravenous use, which means it is infused directly into a vein. The trial also uses a placebo comparator of 0.9% sodium chloride intravenous infusion solution, which is a salt-water solution given in the same way.
What do the clinical trials show?
There is one registered clinical trial of IMC S118AI. It is a Phase 1/1b study, which is the earliest stage of testing in humans. Phase 1 studies focus on safety, tolerability, and how the body handles a drug. The trial has been authorised, meaning it has received approval to start, but it is not yet recruiting participants.
The trial plans to enrol 154 participants with type 1 diabetes. The primary outcomes are the incidence and severity of adverse events, treatment-emergent adverse events, and serious adverse events. The study will also measure changes in safety laboratory parameters, vital signs, and electrocardiogram, as well as the incidence of dose interruptions, reductions, and discontinuations. The study is interventional, meaning participants receive the drug or placebo according to the trial plan.
What side effects are known?
The registry record does not list specific side effects for IMC S118AI. The trial is designed to measure the incidence and severity of adverse events, treatment-emergent adverse events, and serious adverse events. No supplementary sources are available to describe known side effects.