Phase 1 Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 to 60 years old at the time of signing the consent form
• People who have been diagnosed with Type 1 diabetes for at least 12 months
• People who have been using an insulin pump or taking multiple daily insulin injections (both a long-acting and short-acting insulin) consistently for at least 3 months
• People whose blood test shows a very low level of a protein called C-peptide (measured at ≤0.3 nmol/L when blood sugar is above a certain level), which indicates the body is producing little to no insulin on its own
• People whose HbA1c (a measure of average blood sugar over several months) is 8.5% or below
• People with a body mass index (BMI) between 18.5 and 30.0
• People who weigh at least 50 kg
• Female participants must not be pregnant or breastfeeding, and must have gone through menopause (no periods for more than 12 months), confirmed by a hormone blood test at screening
• Male participants must either be surgically sterile, not sexually active, or be using an accepted form of contraception with their partner if there is any possibility of pregnancy
• People who have suitable veins that allow blood to be drawn without difficulty
• People who are able to give informed consent and are willing to follow all study procedures for the full duration of the trial

Who may not be able to join:

• People who have advanced diabetes-related eye disease (such as proliferative retinopathy or maculopathy), severe stomach-emptying problems (gastroparesis), or severe nerve damage, particularly affecting automatic body functions — as determined by the investigating doctor
• People who have had 2 or more episodes of severe low blood sugar, 1 or more episodes of diabetic ketoacidosis, or a hospital visit for uncontrolled diabetes in the 6 months before screening
• People who are not able to keep their diet consistent throughout the study
• People with high blood pressure above 150/90 mmHg at screening, or who are taking more than 2 blood pressure medications, or whose blood pressure medication doses have not been stable for at least 3 months
• People currently taking any medications listed on the trial's prohibited medications list (confirm with trial site)
• People who have had major surgery in the 6 months before screening
• People with a history of a serious allergic reaction to any ingredient in the study treatment
• People with kidney disease or poor kidney function (a kidney filtration rate below 60 mL/min/1.73m²) at screening
• People with very high triglyceride (blood fat) levels above 500 mg/dL at screening
• People with significantly abnormal blood test results at screening (a re-test on a separate day may be allowed)
• People with a history of significant heart disease, including heart failure, heart attack, heart bypass surgery, angioplasty, unstable chest pain requiring medication, mini-stroke, stroke, or bleeding in the brain
• People with clinically significant abnormal physical findings, blood test results, or heart trace (ECG) results at screening — including certain irregular heart rhythm measurements — as determined by the investigating doctor
• People who have had a cancer diagnosis in the past 5 years (certain types of minor skin cancers may be acceptable — confirm with trial site)
• People with other significant ongoing medical conditions affecting major organs or body systems, as judged by the investigating doctor
• People with a personal or family history of blood clotting disorders
• People who have had any active infection (other than a mild cold) in the 30 days before the study drug is given
• People who have received any vaccine in the 2 weeks before entering the clinic
• People with a history of alcohol misuse in the past year, or those who regularly drink more than 2 standard drinks per day (men) or more than 1 standard drink per day (women), or who test positive for alcohol at screening or clinic entry
• People with a history of illegal drug use in the past year, or frequent use of cannabis or THC products in the 6 weeks before screening, or who test positive on a urine drug test at screening or clinic entry
• People who smoke more than 5 cigarettes a day (or equivalent), or lighter smokers who are unwilling or unable to avoid smoking and nicotine products during the in-clinic stay
• People who test positive for hepatitis B, hepatitis C, or HIV at screening
• People with any surgical or medical condition that the investigating doctor believes may affect how the study drug is processed by the body
• People who, in the investigating doctor's opinion, may not be suitable study participants due to mental health concerns or a history of not following medical treatment as directed
• People who have taken part in another clinical trial within 30 days before the study drug is given, or within 5 half-lives of the last dose of a previous trial drug — whichever is the longer period
• People who have donated or lost more than 500 mL of blood or blood products in the 56 days before screening
• People with poor vein access, as assessed by the study team

Important: Always verify eligibility with the trial site directly before applying.