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

Exclusion Criteria

• •Screening (triplicate sitting reading 1-2 minutes apart) BP \> 169 mmHg (systolic) or \> 109 mmHg (diastolic).
• •Systolic blood pressure \< 130 mmHg or \> 169 mmHg and diastolic blood pressure \< 85 mmHg or \> 109 mmHg at randomization (Day -1) or prior to the first dose of study drug (Day 0)
• •Unstable/underlying cardiovascular disease defined as in protocol.
• •Uncontrolled type 2 diabetes mellitus defined as hemoglobin A1c \> 9.0%
• •Clinically significant renal and/or hepatic dysfunction at Screening or at baseline (Day -4) as defined in protocol.
• •Use of non-steroidal anti-inflammatory drugs (excluding prophylactic use of low dose aspirin such as 81 - 162 mg) within 2 weeks prior to administration of study drug or anticipated use during the study period.
• •Pregnant or lactating females.
• •Known latex allergy (Ambulatory Blood Pressure Monitor \[ABPM\] unit contains latex in bladder and tubing).
• •Known history of or active drug or alcohol abuse within the 12 months prior to Screening and/or positive drug screen or detection of alcohol at Screening or at baseline (Day -4).
• •Positive for Human Immunodeficiency Virus (HIV) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies.
• •Participation in any other study and have received any other investigational drug or device within 30 days prior to the Screening visit or are taking part in a non-drug study which in the opinion of the Investigator would interfere with the outcome of the study.
• •Major surgery, donated or lost \> or = 1 unit of blood (approximately 500 mL) within 1 month prior to randomization (Day -1) or display evidence of volume depletion (i.e., postural hypotension) not otherwise explained by the subject's antihypertensive medication regimen.
• •Other medical or psychiatric condition which in the opinion of the Investigator would place the subject at increased risk, would preclude obtaining voluntary consent, or would interfere with the interpretation of the results of the study.