NCT05247528

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: E-Star BioTech, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Resistant Hypertension
• Difficult to Control Hypertension

Interventions

Type	Name	Description
DRUG	MANP	Novel designer peptide to represent a pGC-A/cGMP therapeutic
DRUG	Placebo	Placebo Comparator

Timeline

• Start date: 2021-12-20
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2022-02-21
• Last updated: 2022-11-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study