Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
Completed · Phase 1 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.
Key facts
- Study ID
- NCT04862741
- Run by
- Landos Biopharma Inc.
- People needed
- 39
- Starts
- 2021-05-05
- Expected to finish
- 2022-10-05
- Last updated by the study team
- 2023-02-15
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Avant Research Associates LLC — Huntsville, Alabama, United States
- Om Research LLC — Lancaster, California, United States
- Allameh Medical Corporation — Mission Viejo, California, United States
- California Medical Research Associates, Inc. — Northridge, California, United States
- Clinical Research of California — Walnut Creek, California, United States
- I.H.S Health LLC — Kissimmee, Florida, United States
- University of Miami Crohn's and Colitis Center — Miami, Florida, United States
- Valencia Medical and Research Center — Miami, Florida, United States
- Care Access — Orlando, Florida, United States
- Gastroenterology Associates of Pensacola, P.A. — Pensacola, Florida, United States
- Atlanta Center for Gastroenterology, P.C. — Decatur, Georgia, United States
- Care Access — New York, New York, United States
- Care Access — Lumberton, North Carolina, United States
- Optimed Research, LTD — Columbus, Ohio, United States
- Care Access — Pottsville, Pennsylvania, United States
- Galen Medical Group — Chattanooga, Tennessee, United States
- Avant Research Associates, LLC — Austin, Texas, United States
- Biopharma Informatics, LLC — Houston, Texas, United States
- LinQ Research, LLC — Pearland, Texas, United States
- Southern Star Research Institute, LLC — San Antonio, Texas, United States
- Victoria Gastroenterology — Victoria, Texas, United States
- Care Access Research, Salt Lake City — Salt Lake City, Utah, United States
- Communal Enterprise I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital of Dnipropetrovsk Regional Counsil, cont. — Dnipro, Ukraine
- Communal Non-commercial Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council — Ivano-Frankivsk, Ukraine
- Medical Center 'Ok!Clinic+' of Copmany with limited liability "International institue of Clinical Research" — Kyiv, Ukraine
Full record on ClinicalTrials.gov
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