Actively Recruiting
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-04-07
64
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or above
- Women of childbearing potential must agree to use one form of birth control during the study and two forms during the intervention and up to 7 days after infusion
- Willingness to return for all study visits and complete all study tasks
- Ability to provide written informed consent
You will not qualify if you...
- Pregnancy, planned pregnancy during the study, or current breastfeeding
- Use of supplements or medications (except oral contraceptives) within 8 weeks before enrollment
- Known allergies or intolerance to Fx-5A peptide-lipid complex components
- Known allergies or intolerance to eggs or egg components
- Fever or febrile illness within 5 days before dosing
- Untreated or uncontrolled hypertension
- Body mass index (BMI) of 30 kg/m2 or higher
- Blood donation of 500 mL or more within 2 months before dosing
- Treatment with another investigational drug within 1 month or 5 half-lives before dosing
- Laboratory abnormalities (grade 2 or higher) in liver, muscle, inflammation, blood sugar, kidney, thyroid, or blood cell tests
- Kidney function with eGFR less than 90 mL/min/1.73m2 or liver impairment
- Any condition that may compromise safety or data accuracy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
Joy Lynne V Freeman
CONTACT
M
Marcelo J Amar, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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