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
| Status: | Archived |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2010 |
| End Date: | October 2011 |
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)
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).
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