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Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT05247528•E-Star BioTech, LLC

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (5)

USA Clinical Site 03

Anniston, Alabama, United States

USA Clinical Site 01

Tustin, California, United States

USA Clinical Site 02

DeLand, Florida, United States

USA Clinical Site 04

Decatur, Georgia, United States

USA Clinical Site 05

Owensboro, Kentucky, United States

Key Dates

Start Date

December 20, 2021

Primary Completion Date

October 31, 2022

Completion Date

October 31, 2022

Last Updated

November 29, 2022

Enrollment

ACTUAL participants

Conditions

Resistant HypertensionDifficult to Control Hypertension

Interventions

MANP

DRUG

Placebo

DRUG

Endothelin-1 Receptor Blockade in Resistant Hypertension

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Resistant Hypertension

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RECRUITING

Symplicity China Study

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Resistant Hypertension

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RECRUITINGPHASE2

Endocalyx in Treatment Resistent Hypertension

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Treatment Resistant Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Endothelin-1 Receptor Blockade in Resistant Hypertension

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