A First in Human Study of the Safety, Tolerability, and the Physiologically Based Pharmacokinetics of XFB19 in Healthy Adult Volunteers.

Xfibra, Inc. is conducting this clinical research study to test a potential new drug called XFB19 that is being developed for inflammatory/fibrotic diseases.

Although current medications are available to improve health and survival in patients with inflammatory/fibrotic diseases no specific pharmacotherapy has proven curative against Acute Respiratory Distress Syndrome (ARDS), liver cirrhosis , or Idiopathic Pulmonary Fibrosis (IPF). The advantages of XFB19 over currently available therapies are its target specificity, in that it only affects a carefully selected target which may allow recovery from inflammatory/fibrotic diseases, and potentially reverse tissue fibrosis.

Although many laboratory and animal studies have been completed, this is the first time XFB-19 is being tested in humans. Therefore, side effects in humans are unknown.

This study will be conducted in two parts - Part A (single dose) and Part B (multiple dosing). The purpose and main goals of this study are:

* To determine whether XFB19 is safe and well tolerated in humans * To determine a safe dose of XFB19 to be used in future studies in patients. * To test how much XFB19 gets into the blood and how long it takes to be cleared from the body * To measure the activity of XFB19 in blood.

XFB19 is considered experimental because it has not yet been approved by the FDA (Food and Drug Administration) in the USA, or any other regulatory agency responsible for approving medicines. There may be risks in taking this experimental drug that are unknown.