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

• Status: Recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: E-Star BioTech, LLC
• Collaborators: Integrium; Mayo Clinic

Criteria

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.