A Study of PALI-2108 in Healthy Volunteers, Patients With Ulcerative Colitis, and Patients With F… (NCT07428096) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of PALI-2108 in Healthy Volunteers, Patients With Ulcerative Colitis, and Patients With Fibrostenosing Crohn's Disease
Canada6 participantsStarted 2025-10-17
Plain-language summary
This 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form (ICF)
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Aged at least 18 years but not older than 60 years
✓. Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively
✓. Non- or ex-smoker
✓. Healthy adult male or female
✓. Have no clinically significant (CS) diseases captured in the medical history or evidence of CS findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator
✓. Provision of signed and dated ICF
Exclusion criteria
✕. Female who is lactating
✕. Female who is pregnant according to the pregnancy test at Screening or Day -1
What they're measuring
1
Safety and tolerability of PALI-2108 administered for 14 days.
✕. History of significant hypersensitivity to PALI-2108 or any other PDE-4 inhibitor (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
✕. Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability or transit
✕. Presence of history of renal disease
✕. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
✕. An active infection or a recent history of serious infections 30 days prior to first study drug administration
✕. Presence of CS vital sign and/or ECG abnormalities (based on the average of triplicate ECG readings) at the Screening visit, as defined by medical judgment