Trials / Recruiting
RecruitingNCT05552755
Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)
A Phase 1b-2, Multicenter, Trial to Evaluate the Efficacy, Safety, Pharmacokintetics, and Pharmacodynamics of REC-4881 in Patients With Familial Adenomatous Polyposis (FAP)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 67 (estimated)
- Sponsor
- Recursion Pharmaceuticals Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, two-part trial in participants with FAP.
Detailed description
This is a Phase 1b/2 trial to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of REC-4881 in participants with 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | REC-4881 | REC-4881 capsules |
| DRUG | Placebo | Placebo capsules |
Timeline
- Start date
- 2023-07-10
- Primary completion
- 2027-06-01
- Completion
- 2027-09-01
- First posted
- 2022-09-23
- Last updated
- 2026-04-16
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05552755. Inclusion in this directory is not an endorsement.