Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess safety and tolerability and determine the pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cebix Incorporated

Criteria

Key Inclusion Criteria:

• Give informed consent

• Aged 18 to 55 years (Part 1), Ages 18 to 65 years (Part 2)

• Stable type 1 diabetes mellitus (T1DM) for a minimum of 5 years

• Body mass index of 18-35 kg/m2

• Be C-peptide deficient (assessed by fasting concentration level)

• Normal renal function (assessed by serum creatinine)

• Be in good general health (besides T1DM)

• Have abnormal sural nerve conduction velocity observed bilaterally (Part 2 only)

Key Exclusion Criteria:

• Any significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, or gastrointestinal condition or disease

• Unstable glucose control

• Have had a islet cell, kidney, and/or pancreas transplant

• Blood loss or blood donation within 56 days

• Drug or alcohol abuse (within 2 years) or recreational drug use (within 3 months)

• History or positive test result for Hepatitis B, C, and/or HIV

• Treatment with medication for peripheral neuropathy within 30 days