Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response of Vasomera (PB1046) Injection Following a Single Subcutaneous Dose in Subjects With Stage 1 or 2 Essential Hypertension
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.
|Essential Hypertension||Drug: Vasomera (PB1046) Drug: 0.9% Sodium Chloride||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Safety/Tolerability [ Time Frame: Day -45 to Day 28 ]
- Incidence and severity of adverse events (AEs) and their relationship to Vasomera (including AEs of interest, gastrointestinal effects, injection site reaction and hypotension)
- Changes in vital signs, ECGs, and safety laboratory parameters from baseline
- Discontinuations from the study due to AEs
- Pharmacokinetics [ Time Frame: Pre-dose, 1, 2, 3, 6, 8 and 12 hours post-dose, 24, 30 and 36 hours, Days 2, 3, 6, 7, 14, 21 and 28 ]Maximum peak steady state drug concentration (Cmax), Time to Cmax (Tmax), Elimination Rate Constant, t1/2, AUC(inf), Total serum clearance, and Volume of distribution of Vasomera
- Pharmacodynamics [ Time Frame: ABPM (Day 0 and Day 6), Telemetry (Day -1, 0, 1 and Day 2 and 3 as needed), Daily home BP monitoring and Vital Signs (up to 3x times/day) during each visit (Day -35, -14, -7, -4, -1, 0, 1, 2, 3, 6, 7, 14, 21 and 28) ]
- Change in mean 24-hour systolic blood pressure (SBP) and diastolic blood pressure (DBP) and mean daytime and mean nighttime SBP and DBP compared to placebo
- Change in mean cuff systolic, diastolic and mean arterial blood pressure as compared to placebo
- Mean change from baseline in effect of Vasomera on pulse pressure and heart rate
- Proportion of subjects treated with study drug who were discontinued from treatment due to uncontrolled hypertension (i.e., SBP >169 mmHg or DBP >109 mmHg).
- Immunogenicity [ Time Frame: Pre-dose, Day 14 and Day 28 ]Presence of anti-drug antibodies and anti-VIP antibodies.
|Study Start Date:||January 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Vasomera (PB1046)||
Drug: Vasomera (PB1046)
Single dose of Vasomera
|Placebo Comparator: 0.9% Sodium Chloride||
Drug: 0.9% Sodium Chloride
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523067
|United States, Alabama|
|Anniston, Alabama, United States, 36207|
|United States, California|
|Diablo Clinical Research|
|Walnut Creek, California, United States, 94598|
|United States, Minnesota|
|Prism Research Inc.|
|Saint Paul, Minnesota, United States, 55114|
|United States, Tennessee|
|New Orleans Center for Clinical Research|
|Knoxville, Tennessee, United States, 37920|
|United States, Washington|
|Rainier Clinical Research|
|Renton, Washington, United States, 98057|
|Principal Investigator:||Mark Matson, MD||Prism Research|