Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cebix Incorporated
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Give informed consent;
18-65 years old;
Have type 1 diabetes mellitus for a minimum of 5 years, with a stable diabetic regimen (for at least 3 months);
Have clinical signs of diabetic peripheral neuropathy at screening;
Have abnormal sural nerve conduction observed bilaterally during screening;
Be C-peptide deficient;
Be in good general health (besides having type 1 diabetes mellitus);
Practice effective contraception during and for at least 12 weeks after study participation;
Have a body mass index (BMI) ≥18.0 and \<35.0 kg/m2.
You may not be if
Any significant cardiovascular, hematological, lymphatic, immunologic, urologic, dermatologic, psychiatric, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, gastrointestinal, or other major disease;
Unstable or inadequate glucose control;
Any clinically significant laboratory value at screening;
Occurrence of a severe, unexplainable hypoglycemic event (defined as requiring the assistance of another individual) within 6 months of Day 0, or recurrent episodes of non-severe hypoglycemia (≥3 per week on average) that are deemed clinically significant by the Investigator;
Have had an islet cell, kidney, and/or pancreas transplant;
If female, is pregnant or lactating;
History of alcohol or substance abuse within 2 years;
Positive screen for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody;
Initiation of treatment or change of dose of medication that could affect peripheral nerve function within 60 days;
Previous treatment with CBX129801 or unmodified C-peptide;
Receipt of an investigational product or therapeutic device, or participation in a drug research study, within a period of 30 days;
Chronic use of oral steroids or use of Ampyra (dalfampridine) within 60 days.
Clareo Health | Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes
