What side effects are associated with this type of intervention?

Common treatments for cardiovascular disease with anti-inflammatory and cardiovascular protective effects, such as statins and aspirin, have several known side effects. Statins can cause muscle pain, liver enzyme abnormalities, and an increased risk of diabetes. Aspirin, while beneficial for preventing blood clots, can lead to gastrointestinal bleeding, peptic ulcers, and an increased risk of hemorrhagic stroke. Both treatments require careful monitoring to balance their benefits against potential adverse effects.

What prior FDA approvals exist?

Several FDA-approved drugs for the treatment of cardiovascular disease have demonstrated anti-inflammatory and cardiovascular protective effects. Statins, such as atorvastatin and simvastatin, are widely used for their ability to lower LDL cholesterol and reduce inflammation, thereby decreasing the risk of heart attacks and strokes. Additionally, anti-platelet agents like aspirin are used to prevent blood clots, further protecting against cardiovascular events. Other therapies include angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), which help manage blood pressure and reduce strain on the heart. These treatments collectively contribute to the management and prevention of cardiovascular disease.

What other types of research exist?

Promising novel alternatives to Fx-5A for cardiovascular disease patients include IMD-0354, a novel IKK inhibitor that has shown efficacy in preventing restenosis after arterial injury, and Genistein-eluting balloons, which have demonstrated anti-inflammatory effects in PCI. Both treatments warrant further research and could be considered for future therapeutic strategies.

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Peptide Complex

Fx-5A Safety and Tolerability in Healthy Volunteers

Phase 1

Recruiting

Led By Marcelo J Amar, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or above

Be older than 18 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called Fx-5A, which mimics a part of good cholesterol to help remove bad cholesterol and reduce inflammation. The study involves healthy adults aged 18 and older who are not pregnant. Participants will receive a single dose of Fx-5A and be monitored for safety and effects over time.

Who is the study for?

Healthy adults over 18, not pregnant, willing to use birth control and avoid other studies. Excludes those with allergies to Fx-5A components, recent blood donors, kidney or liver issues, uncontrolled hypertension, recent investigational drug use or certain medication/supplement intake.

What is being tested?

The trial tests the safety and effects of a new heart disease treatment called Fx-5A in healthy volunteers. It involves a hospital stay for monitoring via EKGs and blood tests after receiving an infusion of Fx-5A.

What are the potential side effects?

Potential side effects are not detailed but may include reactions related to the infusion process or ingredients in the peptide complex. Monitoring will assess any changes that could indicate side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been taking supplements or medications for at least 8 weeks, except for birth control pills.

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I am not allergic to any parts of the Fx-5A treatment.

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My blood pressure is high and not managed with medication.

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My kidney or liver function is not normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Assess the PK and PD of the Fx-5A peptide-lipid complex

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

subjects entered into the trial may go thru a 0-4 weeks screening (Screening Phase). On the Intervention phase, subjects will be followed for 7 days which includes: entry criteria assessments and settling at the inpatient unit on Day 0, a single-dose I.V. infusion with data collection on Day 1 followed by 24 hours monitoring (Day 2), a 7-day and 28-day outpatient follow-up visit (Follow-Up Phase).

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cardiovascular disease (CVD) often target inflammation, lipid metabolism, and thrombosis to protect cardiovascular health. Anti-inflammatory agents, like the investigational drug Fx-5A, aim to reduce vascular inflammation, which is a key contributor to atherosclerosis and subsequent cardiovascular events. Statins, another cornerstone of CVD treatment, lower LDL cholesterol and have anti-inflammatory properties, reducing plaque formation and stabilizing existing plaques. Antithrombotic therapies, including aspirin and newer anticoagulants, prevent blood clot formation, reducing the risk of heart attacks and strokes. These mechanisms are crucial for CVD patients as they address the underlying pathophysiological processes, thereby reducing morbidity and mortality associated with cardiovascular events.

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