| Trial ID: | L6644 |
| Source ID: | NCT01293461
|
| Associated Drug: |
Cbx129801
|
| Title: |
Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes
|
| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes|Diabetes Mellitus|Peripheral Diabetic Neuropathy
|
| Interventions: |
DRUG: CBX129801|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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: 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
|
| Sponsor/Collaborators: |
Sponsor: Cebix Incorporated
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
72
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-04
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| Completion Date: |
2012-10
|
| Results First Posted: |
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| Last Update Posted: |
2013-03-01
|
| Locations: |
Escondido, California, United States|Tustin, California, United States|Walnut Creek, California, United States|Aurora, Colorado, United States|Butte, Montana, United States|San Antonio, Texas, United States|Olympia, Washington, United States|Renton, Washington, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01293461
|
