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New drug Fx-5A takes first step toward fighting heart disease

NCT ID NCT04216342

Knowledge-focused Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 6 times

Summary

This study tests whether a new drug called Fx-5A is safe in healthy adults. Researchers will give a single infusion of the drug and monitor participants for side effects. The goal is to see if Fx-5A can be used in future studies for heart disease and inflammation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fx-5A peptide complex
What this could lead to
If safe, this could pave the way for a new treatment for heart disease and inflammation.
What could go wrong
This is a very early, small study in healthy people, not patients. The drug may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: * 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 CRITERIA: * 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.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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