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Completed

NCT Number: NCT05247528

Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects

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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Key information

Conditions

Resistant Hypertension Difficult to Control Hypertension

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USA Clinical Site 03, Anniston, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DTC/RH diagnosed with clinic SBP ≥140 mmHg or DBP ≥ 90 mmHg (or SBP ≥ 130 mmHg or DBP ≥ 80 mmHg for diabetics) while on at least three standard-of-care antihypertensive medications (which must include a diuretic).
  • MDRD eGFR ≥ 30 mL/min.
  • Men and women between the ages of 18 - 80.
  • BMI within the range of 18-40 kg/m2.
  • Women of childbearing potential must not be pregnant and agree to avoid becoming pregnant while receiving study treatment and for 14 days after the last study visit.

Exclusion criteria

  • HbA1c ≥ 8% at Screening.
  • Use of other investigational drugs within 30 days of screening or foreseen use during the study.
  • Inability to comply with study requirements as judged by the Investigator.
  • Pregnant and/or breastfeeding.
  • Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk.

Treatment and study plan

MANP

Drug

Novel designer peptide to represent a pGC-A/cGMP therapeutic

Placebo

Drug

Placebo Comparator

Primary outcomes

  1. Adverse Events

    Time frame: through study completion, an average of 2 months.

    Number and percent of participants with one or more Treatment Emergent Adverse Events (TEAEs) or any serious adverse events (SAEs).

  2. Blood Pressure

    Time frame: From baseline to Days 1-6, Day 12, and 21.

    Change in SBP and DBP

  3. Hematology Hematocrit

    Time frame: From baseline to Day 21.

    Change in Percent Hematocrit

  4. Physical Examination: Body Parts

    Time frame: From baseline to Day 21

    Change in investigator assessment of the condition of body parts (head, throat, abdomen, and extremities)

  5. ECG: QT interval

    Time frame: From baseline to Days 1-6 and Day 21.

    Change in 12-Lead ECG QT Interval

  6. Temperature

    Time frame: From baseline to Days 1-6, Day 12, and 21.

    Change in Temperature

  7. Pulse Rate

    Time frame: From baseline to Days 1-6, Day 12, and 21.

    Change in Pulse Rate

  8. Hematology: Hemoglobin

    Time frame: From baseline to Day 21

    Change in g/dL Hemoglobin

  9. Hematology: Mean Corpuscular Hemoglobin

    Time frame: From baseline to Day 21

    Change in the mean corpuscular hemoglobin.

  10. Hematology: Platelets

    Time frame: From baseline to Day 21

    Change in platelet count

  11. Hematology: RBC distribution

    Time frame: From baseline to Day 21

    Change in red blood cell distribution width

  12. Hematology: RBC

    Time frame: From baseline to Day 21

    Change in red blood cell count

  13. Hematology: WBC

    Time frame: From baseline to Day 21

    Change in white blood cell count

  14. Chemistry: Sodium

    Time frame: From baseline to Day 21

    Change in Sodium concentration.

  15. Chemistry: Potassium

    Time frame: From baseline to Day 21

    Change in Potassium concentration.

  16. Chemistry: Chloride

    Time frame: From baseline to Day 21

    Change in Chloride concentration

  17. Chemistry: Bicarbonate

    Time frame: From baseline to Day 21

    Change in Bicarbonate concentration

  18. Chemistry: Alanine aminotransferase

    Time frame: From baseline to Day 21

    Change in ALT (IU/L)

  19. Chemistry: Aspartate aminotransferase

    Time frame: From baseline to Day 21

    Change in AST (IU/L)

  20. Chemistry: Alkaline phosphatase

    Time frame: From baseline to Day 21

    Change in Alkaline phosphatase (IU/L)

  21. Chemistry: Bilirubin

    Time frame: From baseline to Day 21

    Change in Total bilirubin (mg/dL)

  22. Chemistry: Blood urea nitrogen

    Time frame: From baseline to Day 21

    Change in BUN (mg/dL)

  23. Chemistry: Creatinine

    Time frame: From baseline to Day 21

    Change in Creatinine (mg/dL)

  24. Chemistry: Glucose

    Time frame: From baseline to Day 21

    Change in Glucose (mg/dL)

  25. Chemistry: HbA1c

    Time frame: From baseline to Day 21

    Change in percent HbA1c

  26. Physical Examination: Organs

    Time frame: From baseline to Day 21

    Change in investigator assessment of the condition of organs (skin, eyes, ears, nose, thyroid, lungs, liver, spleen, and lymph nodes)

  27. Abbreviated Neurological Examination

    Time frame: From baseline to Day 21

    Change in investigator assessment of neurological condition

  28. ECG: QTc interval

    Time frame: From baseline to Days 1-6 and Day 21

    Change in 12-Lead ECG QTc (Fridericia's) Interval

Secondary outcomes

  1. Cardiac Metrics: Blood pressures

    Time frame: From Baseline for Day 1-6

    Change in SBP and DBP

  2. Serum creatinine

    Time frame: From Baseline for Day 1-6

    Change in Serum creatinine

  3. MANP

    Time frame: From baseline for Day 1 & Day 5

    Change in amount of Plasma MANP both in plasma.

  4. Immune Response

    Time frame: From baseline for Day 1, Day 5, Day 12, & Day 21

    Change in amount of anti-MANP and anti-ANP

  5. Metabolics

    Time frame: From baseline for Day 1 & Day 5

    Change in amount of non-esterified insulin and glucose.

  6. eGFR,

    Time frame: From Baseline for Day 1-6

    Change in eGFR,

  7. Urine flow rate

    Time frame: From Baseline for Day 1-6

    Change in urine flow rate

  8. Urinary Sodium Excretion

    Time frame: From Baseline for Day 1-6

    Change in amount of urinary sodium excretion

  9. cGMP

    Time frame: from baseline for Day 1 & Day 5

    Change in amount of cGMP both in plasma and urine

  10. Aldosterone

    Time frame: from baseline for Day 1 & Day 5

    Change in amount of aldosterone both in plasma and urine

  11. Cardiac Metrics:

    Time frame: From Baseline for Day 1-6

    Heart Rate

Sponsors and collaborators

Lead sponsor

E-Star BioTech, LLC

Industry

Collaborators

  • Integrium
  • Mayo Clinic

Registry information

Official study title

A Phase 1B, Multiple Ascending Dose Trial Examining The Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects

Acronym: DTC/RHS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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