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

NCT04216342 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 20002920-H-0029
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Assess the safety and tolerability of the Fx-5A peptide complex.

  A complete study is defined by the procedures described up to day 7 after Fx-5A infusion, the intervention phase of the study. A 28 days follow up is designed to study the immunogenicity of the drug. Once a subject completes the day 28 follow up the study is ended for the subject ( end of the study ).

  28 days

Secondary Outcomes (1)

• Assess the PK and PD of the Fx-5A peptide-lipid complex

  28 days

Study Arms (1)

1

EXPERIMENTAL

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).

Biological: Fx-5A peptide complex

Interventions

Fx-5A peptide complex BIOLOGICAL

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.

1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page
• https://www.surveymonkey.com/r/H7XXWJX

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Marcelo J Amar, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 2, 2020
• Study Start: September 29, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 1, 2026

Record last verified: 2025-04-23

Locations

US (1)