NCT04216342 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers
| NCT ID | NCT04216342 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Condition | Cardiovascular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2021-09-29 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 64 participants in total. It began in 2021-09-29 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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\<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.
Contact & Investigator
Marcelo J Amar, M.D.
PRINCIPAL INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Frequently Asked Questions
Who can join the NCT04216342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Cardiovascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04216342 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04216342 currently recruiting?
Yes, NCT04216342 is actively recruiting participants. Contact the research team at joylynne.freeman@nih.gov for enrollment information.
Where is the NCT04216342 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04216342 clinical trial?
NCT04216342 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The principal investigator is Marcelo J Amar, M.D. at National Heart, Lung, and Blood Institute (NHLBI). The trial plans to enroll 64 participants.