Completed
PHASE1
INTERVENTIONAL
NCT05247528
Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
A randomized, double-blind, placebo-controlled multiple ascending dose study in hypertensive subjects on stable doses of at least three hypertensive drugs for at least 6 weeks prior to Screening. The study will consist of screening, PK-unit admittance, and safety follow up periods. Subjects will be randomized at a 6:2 ratio of either MANP or placebo and will be stratified by race in each dosage cohort. The entire first Cohort will be given the lowest dosage with subsequent cohorts progressing sequentially to the higher doses depending on safety and tolerability of the previous cohort. Endpoints not related to the safety reviews will be analyzed after the last patient last visit (LPLV).
Interventions
Name:
MANP
Type:
DRUG
Description:
Novel designer peptide to represent a pGC-A/cGMP therapeutic
Name:
Placebo
Type:
DRUG
Description:
Placebo Comparator
Primary Outcomes
Measure:
Adverse Events
TimeFrame:
through study completion, an average of 2 months.
Description:
Number and percent of participants with one or more Treatment Emergent Adverse Events (TEAEs) or any serious adverse events (SAEs).
Measure:
Blood Pressure
TimeFrame:
From baseline to Days 1-6, Day 12, and 21.
Description:
Change in SBP and DBP
Measure:
Hematology Hematocrit
TimeFrame:
From baseline to Day 21.
Description:
Change in Percent Hematocrit
Measure:
Physical Examination: Body Parts
TimeFrame:
From baseline to Day 21
Description:
Change in investigator assessment of the condition of body parts (head, throat, abdomen, and extremities)
Measure:
ECG: QT interval
TimeFrame:
From baseline to Days 1-6 and Day 21.
Description:
Change in 12-Lead ECG QT Interval
Measure:
Temperature
TimeFrame:
From baseline to Days 1-6, Day 12, and 21.
Description:
Change in Temperature
Measure:
Pulse Rate
TimeFrame:
From baseline to Days 1-6, Day 12, and 21.
Description:
Change in Pulse Rate
Measure:
Hematology: Hemoglobin
TimeFrame:
From baseline to Day 21
Description:
Change in g/dL Hemoglobin
Measure:
Hematology: Mean Corpuscular Hemoglobin
TimeFrame:
From baseline to Day 21
Description:
Change in the mean corpuscular hemoglobin.
Measure:
Hematology: Platelets
TimeFrame:
From baseline to Day 21
Description:
Change in platelet count
Measure:
Hematology: RBC distribution
TimeFrame:
From baseline to Day 21
Description:
Change in red blood cell distribution width
Measure:
Hematology: RBC
TimeFrame:
From baseline to Day 21
Description:
Change in red blood cell count
Measure:
Hematology: WBC
TimeFrame:
From baseline to Day 21
Description:
Change in white blood cell count
Measure:
Chemistry: Sodium
TimeFrame:
From baseline to Day 21
Description:
Change in Sodium concentration.
Measure:
Chemistry: Potassium
TimeFrame:
From baseline to Day 21
Description:
Change in Potassium concentration.
Measure:
Chemistry: Chloride
TimeFrame:
From baseline to Day 21
Description:
Change in Chloride concentration
Measure:
Chemistry: Bicarbonate
TimeFrame:
From baseline to Day 21
Description:
Change in Bicarbonate concentration
Measure:
Chemistry: Alanine aminotransferase
TimeFrame:
From baseline to Day 21
Description:
Change in ALT (IU/L)
Measure:
Chemistry: Aspartate aminotransferase
TimeFrame:
From baseline to Day 21
Description:
Change in AST (IU/L)
Measure:
Chemistry: Alkaline phosphatase
TimeFrame:
From baseline to Day 21
Description:
Change in Alkaline phosphatase (IU/L)
Measure:
Chemistry: Bilirubin
TimeFrame:
From baseline to Day 21
Description:
Change in Total bilirubin (mg/dL)
Measure:
Chemistry: Blood urea nitrogen
TimeFrame:
From baseline to Day 21
Description:
Change in BUN (mg/dL)
Measure:
Chemistry: Creatinine
TimeFrame:
From baseline to Day 21
Description:
Change in Creatinine (mg/dL)
Measure:
Chemistry: Glucose
TimeFrame:
From baseline to Day 21
Description:
Change in Glucose (mg/dL)
Measure:
Chemistry: HbA1c
TimeFrame:
From baseline to Day 21
Description:
Change in percent HbA1c
Measure:
Physical Examination: Organs
TimeFrame:
From baseline to Day 21
Description:
Change in investigator assessment of the condition of organs (skin, eyes, ears, nose, thyroid, lungs, liver, spleen, and lymph nodes)
Measure:
Abbreviated Neurological Examination
TimeFrame:
From baseline to Day 21
Description:
Change in investigator assessment of neurological condition
Measure:
ECG: QTc interval
TimeFrame:
From baseline to Days 1-6 and Day 21
Description:
Change in 12-Lead ECG QTc (Fridericia's) Interval
Trial Information
NCT ID
NCT05247528
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
E-Star BioTech, LLC
Last Updated
December 15, 2025