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NCT04216342 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers
A Phase 1 study of Cardiovascular Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT04216342 is a Phase 1 study of Cardiovascular Disease that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 64 participants, below the 2,713-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04216342, a Phase 1 study of Cardiovascular Disease, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Heart disease is the leading cause of death, disability, and healthcare expense in the United States. Researchers think a new drug called Fx-5A may be useful to treat different cardiovascular diseases and inflammation. Objective: To understand the safety, tolerability, and effects of Fx-5A. Eligibility: Healthy people ages 18 and older who are not pregnant Design: Participants will be screened with: Medical history Physical exam Blood tests Pregnancy test for female participants Participants will stay in the hospital for 36-48 hours. This will include: Blood tests EKGs: Electrodes will be placed on the participant s chest. The patches are connected to cables that will send information from their heart to a machine. Single infusion of Fx-5A. A needle will be used to insert a plastic tube into a vein in the participant s arm. This tube will remain in the arm for the duration of the hospital stay for blood tests. Participants will have follow-up visits day 7 and day 28 after their infusion. At these visits, they will have blood tests and an EKG. Participation will last 5-10 weeks.
Conditions Studied
Interventions
- BIOLOGICAL Fx-5A peptide complex
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-09-29 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04216342
The ClinicalTrials.gov registry entry for NCT04216342 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,713-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (98% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cardiovascular Disease appearing as the primary indexed condition, and to 1 intervention - of which Fx-5A peptide complex is the first listed.
NCT04216342 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04216342 about?
NCT04216342 is a clinical study titled "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers". Background: Heart disease is the leading cause of death, disability, and healthcare expense in the United States. Researchers think a new drug called Fx-5A may be useful to treat different cardiovascular diseases and inflammation. Objective: To understand the safety, tolerability, and effects of ...
What is the current status of trial NCT04216342?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2021-09-29. Estimated completion is 2026-06-30.
What conditions does trial NCT04216342 study?
This clinical trial studies the following conditions: Cardiovascular Disease.
What interventions are being tested in trial NCT04216342?
The interventions under investigation include: Fx-5A peptide complex (BIOLOGICAL).
Who is sponsoring clinical trial NCT04216342?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04216342 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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