Benaroya Research Institute at Virginia Mason | Clinical Trials Unit
Status and phase
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About
This is a multicenter, two-part trial in participants with Familial Adenomatous Polyposis (FAP).
Full description
This is a Phase 1b/2, trial to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of REC-4881 in participants with Familial Adenomatous Polyposis (FAP). This two-part study will treat participants with phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.
Part 1 of the study enrolled seven participants with FAP who are post-colectomy/proctocolectomy. Participants were randomized to Placebo or REC-4881.
Part 2 of the study will treat participants with escalating dose levels of REC-4881 during the Dose Finding. Participates in Cohort Expansion will be treated with a dose(s) to determine the RP2D.
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Interventional model
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73 participants in 5 patient groups, including a placebo group
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Central trial contact
Recursion Pharmaceuticals
Data sourced from clinicaltrials.gov
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