Overview

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response of Vasomera (PB1046) Injection Following a Single Subcutaneous Dose in Subjects With Stage 1 or 2 Essential Hypertension

Status:
Completed

Trial end date:
2012-12-01

Target enrollment:

Participant gender:

Summary

The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of Vasomera (PB1046) administered subcutaneously in adult subjects with Stage 1 or Stage 2 essential hypertension. The secondary objectives of the study are to characterize the pharmacokinetic profile of single ascending doses of Vasomera and the relationship between serum concentrations of Vasomera and change in systolic and diastolic blood pressure as measured by: - Mean change from baseline in 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) as compared to placebo. - Identification of the minimum and maximum decrease in systolic and diastolic blood pressure as measured by ABPM. - Mean change from baseline in cuff systolic and diastolic blood pressure as compared to placebo. - Effect of Vasomera on pulse pressure and heart rate. An additional secondary objective of this study will be to characterize the immunogenicity profile of Vasomera following a single subcutaneous dose.

Phase:

Phase 1

Details

Lead Sponsor:

PhaseBio Pharmaceuticals Inc.

Treatments:

VIP-ELP fusion molecule PB1046