Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers
Eligible age
18–99 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
You may not qualify if…
- ✕ Pregnancy, planned pregnancy (within the study period), or current breastfeeding
- ✕ Subject taking any supplements or medications for at least 8 weeks prior to enrollment (with the exception of oral contraceptives).
- ✕ Known allergies or intolerances to any components of the Fx-5A peptide-lipid complex
- ✕ Known allergies or intolerances to eggs or egg components
- ✕ History of febrile illness within 5 days prior to dosing
- ✕ Hypertension (not treated or uncontrolled\&)
- ✕ BMI equal to or above 30 kg/m\^2
- ✕ Blood donation equal to or above 500 mL within 2 months prior to dosing.
Where it's recruiting
Bethesda
Source: ClinicalTrials.gov · NCT04216342 · last updated 2026-07-15