RECRUITING

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

Conditions

Cardiovascular Disease Pharmacology PEPTIDE ApoA-I Fx-5A

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Intravenous, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers

Quick Facts

Study Start:2021-09-29

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04216342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Joy Lynne V Freeman

CONTACT

(301) 480-7632

joylynne.freeman@nih.gov

Marcelo J Amar, M.D.

CONTACT

(301) 402-0521

mamar@mail.nih.gov

Principal Investigator

Marcelo J Amar, M.D.

PRINCIPAL_INVESTIGATOR

National Heart, Lung, and Blood Institute (NHLBI)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-29

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-09-29

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

Pharmacology
PEPTIDE
ApoA-I
Fx-5A

Additional Relevant MeSH Terms

Cardiovascular Disease