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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| Integrium | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator | Placebo Comparator |
|
|
| MANP | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MANP | Drug | Novel designer peptide to represent a pGC-A/cGMP therapeutic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number and percent of participants with one or more Treatment Emergent Adverse Events (TEAEs) or any serious adverse events (SAEs). | through study completion, an average of 2 months. |
| Blood Pressure | Change in SBP and DBP | From baseline to Days 1-6, Day 12, and 21. |
| Hematology Hematocrit | Change in Percent Hematocrit | From baseline to Day 21. |
| Physical Examination: Body Parts | Change in investigator assessment of the condition of body parts (head, throat, abdomen, and extremities) | From baseline to Day 21 |
| ECG: QT interval | Change in 12-Lead ECG QT Interval | From baseline to Days 1-6 and Day 21. |
| Temperature | Change in Temperature | From baseline to Days 1-6, Day 12, and 21. |
| Pulse Rate | Change in Pulse Rate | From baseline to Days 1-6, Day 12, and 21. |
| Hematology: Hemoglobin | Change in g/dL Hemoglobin | From baseline to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Metrics: Blood pressures | Change in SBP and DBP | From Baseline for Day 1-6 |
| Serum creatinine | Change in Serum creatinine | From Baseline for Day 1-6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucia Gonzalez | E-Star | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA Clinical Site 03 | Anniston | Alabama | 36207 | United States | ||
| USA Clinical Site 01 |
All IPD that underlie results in a publication
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| Placebo |
| Drug |
Placebo Comparator |
|
| Hematology: Mean Corpuscular Hemoglobin | Change in the mean corpuscular hemoglobin. | From baseline to Day 21 |
| Hematology: Platelets | Change in platelet count | From baseline to Day 21 |
| Hematology: RBC distribution | Change in red blood cell distribution width | From baseline to Day 21 |
| Hematology: RBC | Change in red blood cell count | From baseline to Day 21 |
| Hematology: WBC | Change in white blood cell count | From baseline to Day 21 |
| Chemistry: Sodium | Change in Sodium concentration. | From baseline to Day 21 |
| Chemistry: Potassium | Change in Potassium concentration. | From baseline to Day 21 |
| Chemistry: Chloride | Change in Chloride concentration | From baseline to Day 21 |
| Chemistry: Bicarbonate | Change in Bicarbonate concentration | From baseline to Day 21 |
| Chemistry: Alanine aminotransferase | Change in ALT (IU/L) | From baseline to Day 21 |
| Chemistry: Aspartate aminotransferase | Change in AST (IU/L) | From baseline to Day 21 |
| Chemistry: Alkaline phosphatase | Change in Alkaline phosphatase (IU/L) | From baseline to Day 21 |
| Chemistry: Bilirubin | Change in Total bilirubin (mg/dL) | From baseline to Day 21 |
| Chemistry: Blood urea nitrogen | Change in BUN (mg/dL) | From baseline to Day 21 |
| Chemistry: Creatinine | Change in Creatinine (mg/dL) | From baseline to Day 21 |
| Chemistry: Glucose | Change in Glucose (mg/dL) | From baseline to Day 21 |
| Chemistry: HbA1c | Change in percent HbA1c | From baseline to Day 21 |
| Physical Examination: Organs | Change in investigator assessment of the condition of organs (skin, eyes, ears, nose, thyroid, lungs, liver, spleen, and lymph nodes) | From baseline to Day 21 |
| Abbreviated Neurological Examination | Change in investigator assessment of neurological condition | From baseline to Day 21 |
| ECG: QTc interval | Change in 12-Lead ECG QTc (Fridericia's) Interval | From baseline to Days 1-6 and Day 21 |
| MANP | Change in amount of Plasma MANP both in plasma. | From baseline for Day 1 & Day 5 |
| Immune Response | Change in amount of anti-MANP and anti-ANP | From baseline for Day 1, Day 5, Day 12, & Day 21 |
| Metabolics | Change in amount of non-esterified insulin and glucose. | From baseline for Day 1 & Day 5 |
| eGFR, | Change in eGFR, | From Baseline for Day 1-6 |
| Urine flow rate | Change in urine flow rate | From Baseline for Day 1-6 |
| Urinary Sodium Excretion | Change in amount of urinary sodium excretion | From Baseline for Day 1-6 |
| cGMP | Change in amount of cGMP both in plasma and urine | from baseline for Day 1 & Day 5 |
| Aldosterone | Change in amount of aldosterone both in plasma and urine | from baseline for Day 1 & Day 5 |
| Cardiac Metrics: | Heart Rate | From Baseline for Day 1-6 |
| Tustin |
| California |
| 92780 |
| United States |
| USA Clinical Site 02 | DeLand | Florida | 32738 | United States |
| USA Clinical Site 04 | Decatur | Georgia | 30030 | United States |
| USA Clinical Site 05 | Owensboro | Kentucky | 42303 | United States |