Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes

Cebix

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 1 Diabetes; Diabetes Mellitus; Peripheral Diabetic Neuropathy

Treatments: Drug: Placebo; Drug: CBX129801

Study type: Interventional

Funder types: Industry

Identifiers

NCT01293461

CBX129801-PK-101

Details and patient eligibility

About

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.

Full description

This study will be conducted in two parts (Part 1 and Part 2). Part 1 will be conducted in three sequential dose cohorts with dose level escalated for each successive cohort. In Part 2 of the study, a dose regimen determined from the pharmacokinetic data from Part 1 will be administered in up to 40 additional subjects to achieve a target plasma concentration range that represents the most commonly observed physiological C-peptide levels in healthy, non-diabetic individuals.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

CBX129801

Experimental group

Treatment:

Drug: CBX129801

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo