A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of XFB19 in Healthy Adult Volunteers.
Xfibra, Inc.
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.
Description
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 recove…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects. 2. Adult males and females, 18 to 55 years of age (inclusive) at screening. 3. Body mass index ≥ 18.0 and ≤ 35.0 kg/m2 with a body weight ≥ 45 kg at screening. 4. Be non-smokers (including tobacco, e-cigarettes, and marijuana) for at least 1 month prior to first investigational drug administration. 5. Medically healthy without clinically significant abnormalitie…
Interventions
- DrugXFB19
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.
- DrugPlacebo
No active ingredient drug use to blind participants and investigators
Location
- AMR ClinicalKnoxville, Tennessee