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NCT01523067 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response of Vasomera (PB1046) Injection Following a Single Subcutaneous Dose in Subjects With Stage 1 or 2 Essential Hypertension
A Phase 1 study, sponsored by PhaseBio Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT01523067 is a Phase 1 study that has completed, run by PhaseBio Pharmaceuticals. The registered enrollment target is 68 participants.
The verdict
NCT01523067, a Phase 1 study, has completed, sponsored by PhaseBio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of Vasomera (PB1046) administered subcutaneously in adult subjects with Stage 1 or Stage 2 essential hypertension. The secondary objectives of the study are to characterize the pharmacokinetic profile of single ascending doses of Vasomera and the relationship between serum concentrations of Vasomera and change in systolic and diastolic blood pressure as measured by: * Mean change from baseline in 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) as compared to placebo. * Identification of the minimum and maximum decrease in systolic and diastolic blood pressure as measured by ABPM. * Mean change from baseline in cuff systolic and diastolic blood pressure as compared to placebo. * Effect of Vasomera on pulse pressure and heart rate. An additional secondary objective of this study will be to characterize the immunogenicity profile of Vasomera following a single subcutaneous dose.
Interventions
- DRUG 0.9% Sodium Chloride
- DRUG Vasomera (PB1046)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01523067
The ClinicalTrials.gov registry entry for NCT01523067 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PhaseBio Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 0.9% Sodium Chloride is the first listed.
NCT01523067 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01523067 about?
NCT01523067 is a clinical study titled "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response of Vasomera (PB1046) Injection Following a Single Subcutaneous Dose in Subjects With Stage 1 or 2 Essential Hypertension". The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of Vasomera (PB1046) administered subcutaneously in adult subjects with Stage 1 or Stage 2 essential hypertension. The secondary objectives of the study are to characterize the pharmacokinetic pr...
What is the current status of trial NCT01523067?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2012-01. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01523067?
The interventions under investigation include: 0.9% Sodium Chloride (DRUG), Vasomera (PB1046) (DRUG).
Who is sponsoring clinical trial NCT01523067?
This trial is sponsored by PhaseBio Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
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