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First-in-Human Study of XFB19 for Inflammatory/Fibrotic Diseases

This study is testing a new drug called XFB19 for the first time in healthy adult volunteers. XFB19 is being developed for inflammatory/fibrotic diseases like Acute Respiratory Distress Syndrome (ARDS) and liver cirrhosis. Researchers want to see if XFB19 is safe and well-tolerated, and to understand how it moves through the body. You may be able to join if you are a healthy adult between 18 and 55 years old. Success in this study means finding a safe dose of XFB19 to use in future studies with patients. The current status of this study is unclear.

Study design
This is a Phase 1, randomized, double-blind (meaning neither you nor the researchers will know if you're getting XFB19 or a placebo), placebo-controlled study involving about 40 healthy volunteers.
What's involved
You would be admitted to a clinical unit for up to 10 days, during which your heart rate and rhythm would be assessed.
Compensation
Not stated in the trial record.
Follow-up
Your heart rate and rhythm will be assessed during your admission to the clinical unit, which lasts up to 10 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05361733

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

Recruiting
PHASE1Ages 18–55InterventionalTreatment
Xfibra, Inc.
~40 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:XFB19Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events
Measured over During admission to the clinical unit (up to 10 days)
+10 more outcomes measured

Conditions

Focus of the Study: Safety of XFB19

Explore related trials

Healthy Volunteer

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Martina M Buck, Ph.D. · STUDY_CHAIR · Xfibra, Inc.

Who to contact

Mario Chojkier, M.D.
[email protected]
858-864-3588
Email the study team

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What this trial measures

  • Number of participants with adverse eventsDuring admission to the clinical unit (up to 10 days)

    Number of participants with adverse events (using the CTCAE v5.0 grading scale), with abnormal laboratory tests results (hematology, serum chemistry, coagulation, and urinalysis), abnormal vital signs, abnormal ECG parameters, and abnormal physical examination findings.

  • Heart Rate (assessed by ECG)During admission to the clinical unit (up to 10 days)

    ECG parameters include the following: Heart Rate

  • Rhythm (assessed by ECG)During admission to the clinical unit (up to 10 days)

    ECG parameters include the following: Rhythm

  • P wave (assessed by ECG)During admission to the clinical unit (up to 10 days)

    ECG parameters include the following: P wave

  • PR interval (assessed by ECG)During admission to the clinical unit (up to 10 days)

    ECG parameters include the following: PR interval

  • QRS complex (assessed by ECG)During admission to the clinical unit (up to 10 days)

    ECG parameters include the following: QRS complex

  • ST segment (assessed by ECG)During admission to the clinical unit (up to 10 days)

    ECG parameters include the following: ST segment

  • T wave (assessed by ECG)During admission to the clinical unit (up to 10 days)

    ECG parameters include the following: T wave

  • QT interval (assessed by ECG)During admission to the clinical unit (up to 10 days)

    ECG parameters include the following: QT interval

  • Cardiac axis (assessed by ECG)During admission to the clinical unit (up to 10 days)

    ECG parameters include the following: Cardiac axis

  • J-point (assessed by ECG)During admission to the clinical unit (up to 10 days)

    ECG parameters include the following: J-point