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PALI-2108

A Study of PALI-2108 in Healthy Volunteers, Patients With Ulcerative Colitis, and Patients With Fibrostenosing Crohn's Disease

Ensayo de PALISADE BIO, INC. en Fibrostenotic Crohn's Disease (del registro, en inglés).

Fase

Fase 1

Estado

En marcha, sin reclutar

Participantes

6

previstos

Centros

1

Fin del objetivo primario

ene 2026

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en oct 2025.

Qué mide

Safety and tolerability of PALI-2108 administered for 14 days. (del registro, en inglés) (14 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase 1b, open-label, exploratory study designed to evaluate the pharmacodynamic effects of PALI-2108, a phosphodiesterase-4 (PDE4) inhibitor, in patients with fibrostenotic Crohn's disease (FSCD). The study will assess molecular, cellular, and histologic changes in intestinal tissue and peripheral blood following short-term oral administration of PALI-2108. Eligible participants with FSCD will undergo paired ileal pinch biopsies and peripheral blood collection at baseline and after 14 days of PALI-2108 treatment. The primary objective is to elucidate the mechanism of action of PALI-2108 in modulating inflammatory and fibrotic pathways relevant to FSCD pathobiology. Analyses will include single-nucleus RNA sequencing (snRNA-seq) of intestinal biopsies and single-cell RNA sequencing (scRNA-seq) of PBMCs to profile treatment-induced transcriptomic changes across immune and stromal cell populations. The FSCD cohort is part of a larger, multi-part study that also includes a completed Phase 1a first-in-human portion in healthy volunteers and an ulcerative colitis (UC) cohort evaluating clinical and biomarker responses to PALI-2108 treatment.

Más ensayos de PALI

Todos los de PALI, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07428096), actualizada en feb 2026.