NCT01427257

Pharmacokinetic Profile of Two Formulations of PB1023 Following Single Subcutaneous Injection in Subjects With Type 2 Diabetes Mellitus

Phase 1 Open-Label Two-Way Cross Over Study to Assess the Pharmacokinetic Profile of Two Formulations of PB1023 Injection Following a Single Dose Administered By Subcutaneous Injection in Adult Subjects With Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: PhaseBio Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: To compare the pharmacokinetic profile of PB1023 after a single dose administered by subcutaneous injection of two formulations (concentrations). Secondary objectives: To evaluate the safety and tolerability of two formulations of PB1023 Injection administered as a subcutaneous injection in adult subjects with T2DM. To evaluate the impact on the pharmacokinetic profile of PB1023 after a single 90 mg dose of formulation B (100 mg/mL) administered cold at 2 to 8°C by subcutaneous injection.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Single Dose PB1023	Single Dose PB1023 Formulation A
DRUG	Single Dose PB1023	Single Dose PB1023 Formulation B
DRUG	Single Dose PB1023	Single Dose PB1023 Formulation B

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-09-01
• Last updated: 2012-10-01

Locations

1 site across 1 country: United States