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

Recruiting Phase 1 Interventional Study
Cardiovascular Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
64 (estimated)
Sponsor
National Heart, Lung, and Blood Institute (NHLBI) · NIH
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About This Trial
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 w…
Trial Locations
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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…
Contacts

Joy Lynne V Freeman

(301) 480-7632

joylynne.freeman@nih.gov

CONTACT

Marcelo J Amar, M.D.

(301) 402-0521

mamar@mail.nih.gov

CONTACT