Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes

A Randomized, Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CBX129801 (Long-Acting Synthetic C-Peptide) After Subcutaneous Administration in Patients With Type 1 Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Type 1 Diabetes; Peripheral Diabetic Neuropathy
• Intervention / Treatment: Drug: Placebo; Drug: CBX129801

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Escondido, California, United States
    • Tustin, California, United States
    • Walnut Creek, California, United States
  • Colorado
    • Aurora, Colorado, United States
  • Montana
    • Butte, Montana, United States
  • Texas
    • San Antonio, Texas, United States
  • Washington
    • Olympia, Washington, United States
    • Renton, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Subcutaneous injection
Experimental: CBX129801	Drug: CBX129801; Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Plasma CBX129801 will be used to assess the concentration versus time profiles and PK of CBX129801.	For duration of study / 16 months
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

Outcome Measure	Time Frame
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 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 vibration perception threshold (VPT) in patients with type 1 diabetes (Part 2 only)	Predose and 12 weeks postdose

Collaborators and Investigators

• Sponsor: Cebix Incorporated

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: February 8, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Estimate): March 1, 2013
• Last Update Submitted That Met QC Criteria: February 25, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Complications; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetic Neuropathies
• Other Study ID Numbers: CBX129801-PK-101