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Safety Study of Fx-5A for Cardiovascular Disease

This study is testing a new treatment called Fx-5A peptide complex. Researchers want to understand if Fx-5A is safe and well-tolerated, and how it affects the body. This treatment might be helpful for cardiovascular diseases (heart and blood vessel conditions). Healthy adults aged 18 and older can join. To be successful, the study needs to show that Fx-5A is safe and doesn't cause too many side effects over 28 days. The current status of this study is unclear.

Study design
This interventional study plans to enroll 64 healthy volunteers. Participants will receive a single intravenous (IV) infusion of Fx-5A peptide complex.
What's involved
You will have a screening visit including a medical history, physical exam, and blood tests. You will then stay in the hospital for 36-48 hours for the Fx-5A infusion, blood tests, and EKGs (heart rhythm tests).
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability will be assessed for 28 days after the Fx-5A infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04216342

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers

Recruiting
PHASE1Ages 18–99InterventionalTreatment
National Heart, Lung, and Blood Institute (NHLBI)
~64 participants
Updated 2026-09-08 on ClinicalTrials.gov
What's tested:Fx-5A peptide complex

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess the safety and tolerability of the Fx-5A peptide complex.
Measured over 28 days

Conditions

Cardiovascular Disease

Explore related trials

Healthy Volunteers

NCT04216342

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Marcelo J Amar, M.D. · PRINCIPAL_INVESTIGATOR · National Heart, Lung, and Blood Institute (NHLBI)

Who to contact

Joy Lynne V Freeman
[email protected]
(301) 480-7632
Email the study team

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Eligibility criteria

Inclusion

18 years of age or above
Women of childbearing potential must be willing to use an appropriate form of birth control during the course of the study and two forms of birth control during the interventional portion of the study and up to day 7 after infusion
Subject willing to return for all study visits, complete all study-related tasks, and agree not to participate in other research studies from screening visit to study completion
Willingness and capacity to provide written informed consent

Exclusion

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.
Treatment with an investigational drug within a month or 5 half-lives of the investigational drug, whichever is longer, prior to dosing.
Laboratory changes (with CTCAE grade 2 or above): Abnormal levels of ALT, AST, CK, CRP, Alkaline Phosphatase, HbA1c, Urea, Creatinine, TSH, hemoglobin and hematocrit.
Subjects with renal (eGFR\<90 mL/min /1.73m\^2) or liver impairment
Subjects may also be excluded for any reason that may compromise their safety or the accuracy of research data collection.

What this trial measures

  • Assess the safety and tolerability of the Fx-5A peptide complex.28 days

    A complete study is defined by the procedures described up to day 7 after Fx-5A infusion, the intervention phase of the study. A 28 days follow up is designed to study the immunogenicity of the drug. Once a subject completes the day 28 follow up the study is ended for the subject ( end of the study ).