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 65 years old at the time of the first dose.
• People who are generally healthy, with no known ongoing or long-term medical conditions, and no history of autoimmune diseases, as assessed by the study doctor.
• People with a body mass index (BMI) between 18 and 35, and a body weight between 55 kg and 120 kg.
• People who test negative for COVID-19 within 24 hours before each dose.
• People who are capable of becoming pregnant must have a negative pregnancy test and must either avoid sexual activity or use highly effective contraception from the first dose through the entire study period.

Who may not be able to join:

• People with notable findings on physical examination, blood pressure, heart rate, body temperature, heart tracing (ECG), or blood/urine tests at the screening stage, as judged by the study doctor.
• People with a current or past cancer diagnosis.
• People whose kidneys are not filtering at a sufficient rate, or who show abnormal protein levels in their urine at screening (confirm with trial site for specific thresholds).
• People with any disease or condition that the study doctor believes could significantly affect the heart, blood, kidneys, liver, lungs (including ongoing asthma), hormonal system (such as diabetes), nervous system, or digestive system (including stomach ulcers).
• People who have taken part in another clinical trial or received an experimental drug within 28 days before the first dose, or within 5 half-lives of that drug — whichever period is longer.
• People who test positive for HIV (type 1 or 2), hepatitis B, or hepatitis C.
• People who test positive for drugs or alcohol at screening or on the day of the first dose.
• People who have used tobacco or nicotine products at more than the equivalent of 5 cigarettes per week in the 30 days before the first dose. Nicotine use must also be avoided during any inpatient period of the study.
• People who have received a live vaccine within 1 month before screening.
• People who have had their spleen removed.
• People who have received a COVID-19 or influenza vaccine within 2 weeks before screening.
• People who are planning to receive any vaccinations during the study period.
• People with a history of repeated infections without a clear cause.

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