Recruiting
Phase 1

Fx-5A

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT04216342

Conditions

Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Fx-5A peptide complex

Study Details

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.

Conditions

Cardiovascular Disease

Study ID

NCT04216342

Start date

Sep 29, 2021

Status verified date

Mar 30, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

64 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

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).

Interventions

Fx-5A peptide complex

subject will receive a slow I.V. infusion of the Fx-5A peptide complex as described in Table 1. Five to 10 mL of blood will be collected at 30min (+/- 5min\*), 1h (+/- 10min\*), 2h (+/- 10min\*), 4h (+/- 15min\*), 8h (+/- 30min\*), 12h (+/- 30min\*), and 24h (+/- 30min\*) for laboratory tests and to be stored for research tests. The patient will be dismissed, as inpatient, 24-36 hours after the beginning of the treatment.

Primary outcome measure

  • Assess the safety and tolerability of the Fx-5A peptide complex. [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Joy Lynne V Freeman

(301) 480-7632joylynne.freeman@nih.gov

Marcelo J Amar, M.D.

(301) 402-0521mamar@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Sep 8, 2026

Last verified

Mar 30, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-09-08.