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

Phase 1 Recruiting 40 enrolled Xfibra, Inc. PharPoint Research, Inc. · collab Safe Harbor Pharmacovigilance · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2026-02-17
Primary completion: 2026-09-15
Completion: 2026-12-15

Publications

Background Buck M, Chojkier M. A ribosomal S-6 kinase-mediated signal to C/EBP-beta is critical for the development of liver fibrosis. PLoS One. 2007 Dec 26;2(12):e1372. doi: 10.1371/journal.pone.0001372.
Background Buck M, Chojkier M. C/EBPbeta associates with caspase 8 complex proteins and modulates apoptosis in hepatic stellate cells. J Clin Gastroenterol. 2007 Nov-Dec;41 Suppl 3:S295-9. doi: 10.1097/MCG.0b013e31814927d5.
Background Buck M, Chojkier M. C/EBPbeta-Thr217 phosphorylation signaling contributes to the development of lung injury and fibrosis in mice. PLoS One. 2011;6(10):e25497. doi: 10.1371/journal.pone.0025497. Epub 2011 Oct 5.
Background Buck M, Poli V, Hunter T, Chojkier M. C/EBPbeta phosphorylation by RSK creates a functional XEXD caspase inhibitory box critical for cell survival. Mol Cell. 2001 Oct;8(4):807-16. doi: 10.1016/s1097-2765(01)00374-4.
Background Buck M, Solis-Herruzo J, Chojkier M. C/EBPbeta-Thr217 Phosphorylation Stimulates Macrophage Inflammasome Activation and Liver Injury. Sci Rep. 2016 Apr 12;6:24268. doi: 10.1038/srep24268.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	XFB19	Unknown	5 mg	Subcutaneous
Subject	XFB19	Unknown	10 mg	Subcutaneous
Subject	XFB19	Unknown	20 mg	Subcutaneous

Indications

No indication recorded.