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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-20

Study Completion Date

2022-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Resistant Hypertension Difficult to Control Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Comparator

* Subjects randomized to the placebo arm, will receive a single subcutaneous injection each morning daily.
* Intervention: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Comparator

MANP

* Subjects randomized to the experimental arm, will receive a single subcutaneous injection each morning daily. (multiple ascending dose cohorts)
* Intervention: Drug: MANP

Group Type EXPERIMENTAL

MANP

Intervention Type DRUG

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

Interventions

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MANP

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

Intervention Type DRUG

Placebo

Placebo Comparator

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No