MedTrace Logo

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

NCT01523067 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2013-01-04

No results posted yet for this study

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

DRUG

Vasomera (PB1046)

Single dose of Vasomera

DRUG

0.9% Sodium Chloride

Placebo injection

Sponsors & Collaborators

  • PhaseBio Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Matson, MD · Prism Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01523067 on ClinicalTrials.gov