Investigating the effects of Fx-5A in healthy volunteers
An Intravenous, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers
This study is testing a new treatment called Fx-5A in healthy volunteers to see if it can help improve heart health by boosting good cholesterol levels.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT04216342 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new peptide called Fx-5A in healthy individuals. Participants aged 18 and older will undergo medical screenings and stay in the hospital for 36-48 hours, during which they will receive a single infusion of Fx-5A and undergo various tests, including blood tests and EKGs. The study seeks to understand how Fx-5A may contribute to treating cardiovascular diseases by potentially enhancing high-density lipoprotein levels.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 and older who are not pregnant and can comply with study requirements.
Not a fit: Patients with existing cardiovascular conditions or those taking medications that could interfere with the study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic options for preventing cardiovascular diseases.
How similar studies have performed: Previous studies have shown promise with similar approaches involving HDL therapy, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Marcelo J Amar, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Joy Lynne V Freeman
- Email: joylynne.freeman@nih.gov
- Phone: (301) 480-7632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.