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Evaluate REC-4881 in Patients With FAP — TUPELO  

Familial Adenomatous Polyposis Clinical Trial

Official title:
A Phase 1b-2, Multicenter, Trial To Evaluate The Efficacy, Safety, Pharmacokintetics, And Pharmacodynamics Of REC-4881 in Patients With Familial Adenomatous Polyposis (FAP)

Clinical Trial Summary

This is a multicenter, two-part trial in participants with Familial Adenomatous Polyposis (FAP).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05552755
Study type Interventional
Source Recursion Pharmaceuticals Inc.
Contact Recursion Pharmaceuticals
Phone 385-374-1724
Email clinicaltrials@recursionpharma.com
Status Recruiting
Phase Phase 1/Phase 2
Start date July 10, 2023
Completion date July 2026
View Details
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