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NCT05247528 · ClinicalTrials.gov registry record · Phase 1
Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects
A Phase 1 study, sponsored by E-Star BioTech.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT05247528 is a Phase 1 study that has completed, run by E-Star BioTech. The registered enrollment target is 37 participants.
The verdict
NCT05247528, a Phase 1 study, has completed, sponsored by E-Star BioTech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study 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).
Interventions
- DRUG Placebo
- DRUG MANP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2021-12-20 |
| Est. Completion | 2022-10-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05247528
The ClinicalTrials.gov registry entry for NCT05247528 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is E-Star BioTech, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05247528 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05247528 about?
NCT05247528 is a clinical study titled "Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects". 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...
What is the current status of trial NCT05247528?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2021-12-20. Estimated completion is 2022-10-31.
What interventions are being tested in trial NCT05247528?
The interventions under investigation include: Placebo (DRUG), MANP (DRUG).
Who is sponsoring clinical trial NCT05247528?
This trial is sponsored by E-Star BioTech, which has 2 total clinical trials registered on ClinicalTrials.gov.
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