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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-H-0029

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Pharmacology;
PEPTIDE;
ApoA-I;
Fx-5A

Recruitment Keyword(s)

None

Condition(s)

Cardiovascular Disease

Investigational Drug(s)

Fx-5A peptide complex

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: Fx-5A peptide complex

Supporting Site

National Heart, Lung, and Blood Institute

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.

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Eligibility

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, and weight above 247 lb (112.3 kg).

-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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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

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



Joy Lynne V. Freeman
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room B1D713
10 Center Drive
Bethesda, Maryland 20892
(301) 480-7632
joylynne.freeman@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04216342

Additional Linkshttps://www.surveymonkey.com/r/H7XXWJX

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