Clinical Study: Type 1 Diabetes (T1D)
COUR CNP-103
Status: Enrolling
Email: diabetes@benaroyaresearch.org
Phone: (800) 888-4187
Study Summary
The purpose of this study is to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103, an investigational treatment for T1D.
Eligibility Criteria
To join this study, you must:
- Be 12 to 35 years of age
- Have been diagnosed with T1D in the past 6 months
- Be using standard diabetes treatments, including insulin therapy, a nutrition plan, regular exercise, or other relevant care
- You will be able to stay on these treatments during the study
- NOT be taking medicines for T1D that affect the immune system (e.g., cyclosporin, azathioprine, methotrexate, rituximab)
There are additional requirements, which will be explained to you by the study doctor.
What will study participants be asked to do?
Participation in this study will last about 13 months and includes up to 10 visits to the study site. Throughout participation, individuals will be closely monitored and will visit the research site regularly for tests, procedures, and health checks.
The study has 3 parts:
Screening
A study doctor will evaluate you to decide whether this study is a good match. If you decide to join, you will sign the informed consent form (ICF). If you are under 18, your parent or guardian will sign the ICF, and you will sign an assent form.
Study Treatment
You will receive the assigned study treatment and attend regular site visits. Laboratory sample collections, questionnaires, and other testing and procedures will be done depending on the visit.
Follow Up
The study team will monitor your health after your last dose of the assigned study treatment. Laboratory sample collections, questionnaires, and other testing will be done.
