NCT01236404

Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, Study to Assess Safety, Tolerability, PK and PD Response of PB1023 Injection Following Single and Multiple SQ Doses in Adults With Type 2 Diabetes Mellitus

Phase 1/2a, Randomized, Double-Blind Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Response of PB1023 Injection Following Single and Multiple Ascending Subcutaneous Doses in Adult Subjects With Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: PhaseBio Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: To evaluate the safety and tolerability of single and multiple ascending doses of PB1023 administered as a subcutaneous (SC) injection in adult subjects with T2DM. Secondary objectives: 1. To characterize the pharmacokinetic profile of PB1023 after single and multiple ascending doses of PB1023. 2. To assess the pharmacodynamic response of various single and multiple doses of PB1023 (daily fasting plasma glucose, and serial glucose, c-peptide and insulin levels in response to a liquid Mixed Meal Tolerance Test (MMTT).

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl)
DRUG	Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)	Once weekly injections for up to four weeks

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-11-08
• Last updated: 2013-05-21

Locations

3 sites across 1 country: United States