Back to resultsSafety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes, Diabetes Mellitus, Peripheral Diabetic Neuropathy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBX129801
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CBX129801
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
To evaluate the technique of sensory nerve conduction velocity (SNCV) in the sural nerves in patients with type 1 diabetes mellitus.
To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation.
To evaluate the technique of motor nerve conduction velocity (MNCV) in the peroneal nerves in patients with type 1 diabetes mellitus.
To evaluate the technique of vibration perception threshold (VPT) in patients with type 1 diabetes (Part 2 only)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01293461
Brief Title
Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cebix Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Diabetes Mellitus, Peripheral Diabetic Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBX129801
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CBX129801
Intervention Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
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.
Description
Plasma CBX129801 will be used to assess the concentration versus time profiles and PK of CBX129801.
Time Frame
For duration of study / 16 months
Title
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.
Time Frame
For duration of study / 16 months
Secondary Outcome Measure Information:
Title
To evaluate the technique of sensory nerve conduction velocity (SNCV) in the sural nerves in patients with type 1 diabetes mellitus.
Time Frame
Predose and 6 and 12 weeks postdose
Title
To assess the immunogenicity of CBX129801 by occurrence of anti-CBX129801 antibody formation.
Time Frame
For duration of study / 16 months
Title
To evaluate the technique of motor nerve conduction velocity (MNCV) in the peroneal nerves in patients with type 1 diabetes mellitus.
Time Frame
Predose and 6 and 12 weeks postdose
Title
To evaluate the technique of vibration perception threshold (VPT) in patients with type 1 diabetes (Part 2 only)
Time Frame
Predose and 12 weeks postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Escondido
State/Province
California
Country
United States
City
Tustin
State/Province
California
Country
United States
City
Walnut Creek
State/Province
California
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Butte
State/Province
Montana
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Olympia
State/Province
Washington
Country
United States
City
Renton
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes
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