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

NCT05361733 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-01

No results posted yet for this study

Summary

Xfibra, Inc. is conducting a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study of the safety, tolerability, and physiologically-based pharmacokinetics (PK) of single and multiple ascending doses of XFB19 in healthy adult volunteers.

Conditions

  • Focus of the Study: Safety of XFB19

Interventions

DRUG

XFB19

The site-specific phosphorylation of the CCAAT/enhancer binding protein β (C/EBPβ) on Threonine266 (phospho-C/EBPβThr266) is critical for the priming and activation pathways, signals 1 and 2 of the NLRP3 inflammasome, that result in its full induction, causal to systemic inflammation critical to the morbidity and mortality of inflammatory/fibrotic diseases. Phospho-C/EBPβThr266 is also essential for the mesenchymal myofibroblastic cell cycle checkpoint failure and transition that results in the inappropriate tissue repair and pathological tissue fibrosis. XFB19 is a first-in-class, rationally-designed drug. It is homeostatic, and in preclinical studies, effectively, safely, and selectively inhibits phospho-C/EBPβThr266, the pathological inflammatory-fibrotic complications of NLRP3 inflammasome activation and synergistic myofibroblastic transition, reversing the pathology towards homeostasis, and fulfilling the precision medicine objectives.

DRUG

Placebo

No active ingredient drug use to blind participants and investigators

Sponsors & Collaborators

  • PharPoint Research, Inc.

    collaborator INDUSTRY

  • Safe Harbor Pharmacovigilance

    collaborator UNKNOWN

  • Xfibra, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-17
Primary Completion
2026-09-15
Completion
2026-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05361733 on ClinicalTrials.gov