NCT01523067

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

Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Response of Vasomera (PB1046) Injection Following a Single Subcutaneous Dose in Adult Subjects With Stage 1 or Stage 2 Essential Hypertension

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: PhaseBio Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Vasomera (PB1046)	Single dose of Vasomera
DRUG	0.9% Sodium Chloride	Placebo injection

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-02-01
• Last updated: 2013-01-04

Locations

5 sites across 1 country: United States