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

Conditions

• Focus of the Study: Safety of XFB19

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• XFB19 — DRUG
  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.
• Placebo — DRUG
  No active ingredient drug use to blind participants and investigators

Study Details

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.

Key Dates

Start date

Feb 17, 2026

Status verified

Apr 2026

Primary completion

Sep 15, 2026

Completion

Dec 15, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: XFB19 administered SC.
  Part A: XFB19 SC injection at the following dose levels: * Cohort A1: 5 mg (or placebo vehicle , same volume) * Cohort A2: 10 mg (or placebo vehicle , same volume) * Cohort A3: 20 mg (or placebo vehicle , same volume) Part B: XFB19 SC injection at the 2 highest acceptable dose levels from Part A: * Cohort B1: second highest acceptable dose level from Part A (or placebo vehicle , same volume) * Cohort B2: highest acceptable dose level from Part A (or placebo vehicle , same volume)
• Placebo Comparator: Placebo
  10 healthy volunteers will be randomized and assigned to the Placebo arm in Part A (Cohorts A1, A2 and A3) and Part B (Cohorts B1 and B2).

Primary Outcome Measure

Number of participants with adverse events [ Time Frame: During admission to the clinical unit (up to 10 days) ]

Central Contacts

• Mario Chojkier, M.D.
  858-864-3588
  [email protected]
• Ed Parsley, D.O
  713-899-2450
  [email protected]

Locations (1)

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