Clinical Trial Details
| Trial ID: | L5533 |
| Source ID: | NCT01478399 |
| Associated Drug: | Pb1023 Injection |
| Title: | Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: PB1023 Injection |
| Outcome Measures: | Primary: Pharmacokinetics, The PK analysis population will consist of subjects that complete the study and have sufficient data for PK analysis. The following parameters will be evaluated: t1/2, AUC(0-inf), Tmax, Cmax, elimination rate constant, CL/F, Vz/F., Pre-Dose, 1, 4, 8 and 12 hours post-dose, Day 1, 2, 3, 5, 7, 10, 14, 21 and 28 | Secondary: Safety/Tolerability, Safety and tolerability will be evaluated by analyses of the incidence of adverse events. Vital signs, ECGs and safety laboratory parameters will be presented descriptively., Screening to Final Visit (Approximately 6 weeks) |
| Sponsor/Collaborators: | Sponsor: PhaseBio Pharmaceuticals Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 16 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2011-12 |
| Completion Date: | 2012-10 |
| Results First Posted: | |
| Last Update Posted: | 2013-04-15 |
| Locations: | Prism Research, Saint Paul, Minnesota, 55114, United States|New Orleans Center for Clinical Research, Knoxville, Tennessee, 37920, United States |
| URL: | https://clinicaltrials.gov/show/NCT01478399 |
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