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

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Dec 31, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called Fx-5A, which researchers believe might help treat heart disease and related inflammation. The main goal is to find out if Fx-5A is safe to use and how it affects the body. The trial is looking for healthy volunteers aged 18 and older. However, women who can get pregnant must agree to use two forms of birth control during the study.

Participants will spend about 36 to 48 hours in the hospital, where they will undergo various tests, including blood tests and heart monitoring. They will receive a single infusion of the drug through a small tube placed in their arm. After the hospital stay, there will be follow-up visits at one and four weeks to check on their health with more tests. Overall, participation in the trial will last between 5 to 10 weeks. It’s important to note that individuals with certain health conditions, such as uncontrolled high blood pressure or significant allergies, may not be eligible to participate.

Gender

ALL

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.