Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes

Phase 1

Completed

• Conditions: Peripheral Diabetic Neuropathy; Type 1 Diabetes; Diabetes Mellitus
• Interventions: Drug: CBX129801; Drug: Placebo

• Registration Number: NCT01293461
• Lead Sponsor: Cebix Incorporated

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-02-08
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Study Start: 2011-04
• Primary Completion: 2012-08
• Study Completion: 2012-10
• Status Verified: 2013-02
• Disposition First Submitted: 2013-02-25
• Disposition First Submitted QC: 2013-02-25
• Last Update Submitted: 2013-02-25
• Disposition First Posted: 2013-03-01
• Last Update Posted: 2013-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBX129801	CBX129801	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
To assess the single and multiple dose pharmacokinetics of plasma CBX129801 after subcutaneous (SC) administration of CBX129801 by estimating parameters of Cmax, Tmax, Cmin, AUClast, AUCinf, Tlag, Cav, CL/F, Vz/F, and half life.	For duration of study / 16 months	Plasma CBX129801 will be used to assess the concentration versus time profiles and PK of CBX129801.
To assess the safety and tolerability of CBX129801 when administered SC by adverse events, injection site assessments, clinical laboratory tests, vital signs, physical examinations, and electrocardiograms.	For duration of study / 16 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the technique of motor nerve conduction velocity (MNCV) in the peroneal nerves in patients with type 1 diabetes mellitus.	Predose and 6 and 12 weeks postdose
To evaluate the technique of sensory nerve conduction velocity (SNCV) in the sural nerves in patients with type 1 diabetes mellitus.	Predose and 6 and 12 weeks postdose
To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation.	For duration of study / 16 months
To evaluate the technique of vibration perception threshold (VPT) in patients with type 1 diabetes (Part 2 only)	Predose and 12 weeks postdose