A First-in-human Study of the Safety, Tolerability, and PK of XFB-19 in Healthy Adult Volunteers

Idiopathic Pulmonary Fibrosis (IPF) Clinical Trial

Official title: A Phase 1, Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of XFB-19 in Healthy Adult Volunteers

Status Not yet recruiting

Clinical Trial Summary

Xfibra, Inc. is conducting a phase 1, randomised, double-blind, placebo-controlled, first-in-human study of the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of XFB-19 in healthy adult volunteers in lung fibrosis.

Clinical Trial Description

Xfibra, Inc. is conducting this clinical research study to test a potential new drug called XFB 19 that is being developed for idiopathic pulmonary fibrosis (IPF).

Idiopathic pulmonary fibrosis (IPF) is a serious lung disease. When you breathe in (inhale), oxygen moves through tiny air sacs in your lungs and into your bloodstream. From there, it travels to your organs. IPF causes scar tissue to grow inside your lungs and makes it hard to breathe. It gets worse over time. IPF scar tissue is thick, like the scars you get on your skin after a cut. It slows oxygen flow from your lungs to your blood, which can keep your body from working as it should. Idiopathic means the cause is unknown. IPF usually affects people who are around 70 to 75 years old and is rare in people under 50. IPF has been linked to exposure to certain types of dust, such as metal or wood dust, viral infections, a family history of IPF (around 1 in 20 people with IPF has another family member with the condition), acid reflux disease, and smoking. It is not known whether some of these factors directly cause IPF. The progressive lung injury, inflammation, and lung scarring lead to dyspnea (shortness of breath), limited physical activity, malaise, and muscle wasting with most deaths in patients with IPF resulting from progression of scar tissue in the lungs.

Although current medications are available to improve health and survival in patients with IPF, the medications are not curative, and are associated with adverse effects in a significant percentage of IPF patients. The advantages of XFB-19 over currently available therapies are its specificity, in that it only affects a carefully selected target which may allow recovery from IPF and lung injury, and potentially reverse lung 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 XFB-19 is safe and well tolerated in humans

• To determine a safe dose of XFB-19 to be used in future studies

• To test how much XFB-19 gets into the blood and how long it takes to be cleared from the body

• To determine the effect of XFB-19 on the body by performing blood tests

XFB-19 is considered experimental because it has not yet been approved by the TGA (Therapeutic Goods Administration) in Australia, or any other regulatory agency responsible for approving medicines. There may be risks in taking this experimental drug that are unknown. ;

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Idiopathic Pulmonary Fibrosis (IPF)
• Pulmonary Fibrosis

• NCT number: NCT05361733
• Study type: Interventional
• Source: Xfibra, Inc.
• Contact: Ed Parsley, D.O.
• Phone: 713-899-2450
• Email: eparsley@att.net
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 5, 2022
• Completion date: March 9, 2023