Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects (DTC/RHS)

E-Star BioTech

Status and phase: Completed; Phase 1

Conditions: Resistant Hypertension; Difficult to Control Hypertension

Treatments: Drug: MANP; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05247528

ES_MANP_21-01

Details and patient eligibility

About

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).

Enrollment: 37 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups, including a placebo group

Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

MANP

Experimental group

Description:

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

Treatment:

Drug: MANP