Last reviewed · How we verify
NCT06663605
Phase 1 Study Evaluating PALI-2108 in Healthy Volunteers and Ulcerative Colitis Patients.
Phase 1 trial testing PALI-2108 in Ulcerative Colitis (UC) in 89 participants. Completed in 7 August 2025.
7 July 2025
Quick facts
| Lead sponsor | Palisade Bio |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 89 |
| Start date | 5 November 2024 |
| Primary completion | 7 July 2025 |
| Estimated completion | 7 August 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- PALI-2108 — full drug profile →
- PALI-2108 Placebo
Conditions studied
- Ulcerative Colitis (UC) — all drugs for Ulcerative Colitis (UC) →
- Healthy Volunteer — all drugs for Healthy Volunteer →
Sponsor
Palisade Bio — full company profile →
Who can join
Adults 18 to 60, any sex, with Ulcerative Colitis (UC) or Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
PALI-2108 is a new oral medication designed to treat ulcerative colitis (UC) by targeting the intestines. It works as a phosphodiesterase-4 (PDE4) inhibitor prodrug, meaning it becomes active only after being processed by bacteria in the colon. This targeted approach reduces the risk of side effects that can occur with other medications that affect the entire body. Recent studies have shown that patients with active UC, especially those with moderate to severe symptoms, have higher levels of PDE4 and related biomarkers. These biomarkers are linked to the severity of their disease, suggesting that inhibiting PDE4 could help manage UC effectively. The goal of this Phase 1 study is to evaluate the safety, tolerability, and how the body processes (pharmacokinetics) and responds to (pharmacodynamics) PALI-2108 in healthy volunteers. Although there are already PDE4 inhibitors on the market, PALI-2108 is a completely new compound that has not been tested in humans before. The study will involve two parts: first, participants will receive single doses of the drug, and then, in the second part, they will take it twice a day for seven days. The twice-daily dosing schedule is designed to maximize drug exposure in the colon. The investigators will also investigate how food affects the drug's absorption. Additionally, a small group of stable UC patients will be included in the study. These patients will also take PALI-2108 for seven days, allowing us to compare the safety and drug processing between healthy individuals and those with UC. The investigators will monitor important health markers and conduct tests on colon tissue to see how well the drug works and if it causes any changes in the tissue. Including UC patients early in this research is important for understanding how the drug performs in real-world conditions. This data will help refine our approach to identify which patients might benefit most from PALI-2108 in future studies. Overall, this study aims to gather crucial information about PALI-2108's safety and effectiveness, paving the way for new treatment options for patients with ulcerative colitis.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeting Phosphodiesterase 4 in Gastrointestinal and Liver Diseases: From Isoform-Specific Mechanisms to Precision Therapeutics.
Chen C, Liu M, Tao X. · · 2025 · cited 1× · PMID 40564004 · DOI 10.3390/biomedicines13061285
Verify or expand the search:
- PubMed search for NCT06663605
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PALI-2108
Trials testing the same drug.
- NCT07428096 — A Study of PALI-2108 in Healthy Volunteers, Patients With Ulcerative Colitis, and Patients With Fibrostenosing Crohn's D · Phase 1 · active not recruiting
Other recruiting trials for Ulcerative Colitis (UC)
Currently open trials in the same condition.
- NCT07335055 — A Study for HSK47388 in Participants With Ulcerative Colitis · Phase 2 · recruiting
- NCT07271069 — Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis · recruiting
- NCT07245394 — Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD) · recruiting
- NCT07237516 — Zymfentra (Infliximab-dyyb) REal World Cohort STudy · recruiting
- NCT07350577 — Evaluate the Safety, Tolerability, PK and PD of SAD of Intravenously Adminsterted ALTB-268 in Healthy Participants · Phase 1 · recruiting
Other Palisade Bio trials
Trials by the same sponsor.
- NCT07428096 — A Study of PALI-2108 in Healthy Volunteers, Patients With Ulcerative Colitis, and Patients With Fibrostenosing Crohn's D · Phase 1 · active not recruiting
- NCT05470387 — A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection · Phase 3 · terminated
- NCT02836470 — A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06663605 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Palisade Bio
- Last refreshed: 7 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06663605.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing