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NCT05082051
Oral CDX-7108 in Healthy Adults and EPI Subjects
Phase 1 trial testing Part A in Exocrine Pancreatic Insufficiency in 54 participants. Completed in 16 March 2023.
16 March 2023
Quick facts
| Lead sponsor | Société des Produits Nestlé (SPN) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 11 October 2021 |
| Primary completion | 16 March 2023 |
| Estimated completion | 16 March 2023 |
| Sites | 4 locations across New Zealand, Australia |
Drugs / interventions tested
Conditions studied
- Exocrine Pancreatic Insufficiency — all drugs for Exocrine Pancreatic Insufficiency →
Sponsor
Société des Produits Nestlé (SPN) — full company profile →
Who can join
Adults 18 to 75, any sex, with Exocrine Pancreatic Insufficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase 1a/1b single and multiple ascending dose study of oral CDX-7108 in healthy adult subjects and a single dose proof-of-concept study of oral CDX-7108 in subjects with exocrine pancreatic insufficiency. No clinical studies have yet been performed with CDX-7108 and its effects in humans are unknown. This is the first-in-human (FIH) study of CDX-7108, which aims to assess the safety, tolerability, pharmacokinetics (PK) of escalating single and multiple oral doses of CDX-7108 in healthy adult subjects and to evaluate the pharmacodynamics of a single dose of oral CDX-7108 in a proof-of-concept (POC) study in subjects with exocrine pancreatic insufficiency (EPI).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Development of a Potent Engineered Microbial Lipase for the Treatment of Exocrine Pancreatic Insufficiency.
Karamitros CS, Chng C, Hallows WC, Garcia R, et al · · 2026 · PMID 42254859 · DOI 10.1016/j.gastha.2026.100984
Verify or expand the search:
- PubMed search for NCT05082051
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Part A
Trials testing the same drug.
- NCT04510649 — Surufatinib DDI With a PPI and a CYP3A Inducer · Phase 1 · completed
- NCT03474640 — Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies · Phase 1 · completed
Other recruiting trials for Exocrine Pancreatic Insufficiency
Currently open trials in the same condition.
- NCT05710315 — Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure · NA · recruiting
- NCT06477159 — Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency · Phase 4 · recruiting
- NCT05112328 — The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding · NA · recruiting
Other Société des Produits Nestlé (SPN) trials
Trials by the same sponsor.
- NCT07312201 — Oral Nutritional Supplementation in Children With Growth Concerns · NA · not yet recruiting
- NCT07378111 — Vegetarian Tube Feed Study · NA · not yet recruiting
- NCT07439718 — The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome · NA · recruiting
- NCT07341464 — Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends · NA · recruiting
- NCT07127198 — Tolerance and Appetite Reduction of a Nutritional Solution With Intragastric Gelation Properties · NA · 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 NCT05082051 (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 Société des Produits Nestlé (SPN)
- Last refreshed: 20 September 2024
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/NCT05082051.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing