NCT01293461

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Cebix Incorporated · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes
• Diabetes Mellitus
• Peripheral Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	CBX129801	Subcutaneous injection
DRUG	Placebo	Subcutaneous injection

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-08-01
• Completion: 2012-10-01
• First posted: 2011-02-10
• Last updated: 2013-03-01

Locations

8 sites across 1 country: United States