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Cardiovascular DiseaseHealthy volunteersHeart and circulationBiologicalPhase 1

What this study is

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.

What's being tested

  • Fx-5A peptide complex

    Intervention · BIOLOGICAL

    subject will receive a slow I.V. infusion of the Fx-5A peptide complex as described in Table 1. Five to 10 mL of blood will be collected at 30min (+/- 5min*), 1h (+/- 10min*), 2h (+/- 10min*), 4h (+/- 15min*), 8h (+/- 30min*), 12h (+/- 30min*), and 24h (+/- 30min*) for laboratory tests and to be stored for research tests. The patient will be dismissed, as inpatient, 24-36 hours after the beginning of the treatment.

Study details

Official title
An Intravenous, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Conditions
Cardiovascular Disease
Enrolling
64 people
Starts
2021-09-29
Est. completion
2027-06-30
Design
Open-label, single group, Phase 1
Record
View on ClinicalTrials.gov ↗