← Back to all trials
Recruiting
NCT04216342
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers
Conditions: Cardiovascular Disease
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 64
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Location: National Institutes of Health Clinical Center Bethesda Maryland
Summary
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.
...
Eligibility Criteria
* 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\
Source: ClinicalTrials.gov (NCT04216342). StuddyBuddy aggregates publicly available trial information.
