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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: Completed Phase 1 study, sponsored by E-Star BioTech.
NCT05247528 is a Phase 1 study that has completed, run by E-Star BioTech. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Number and percent of participants with one or more Treatment Emergent Adverse Events (TEAEs) or any serious adverse events (SAEs).
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 |
What the finished NCT05247528 record still lists
NCT05247528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05247528 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05247528's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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