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NCT04862741 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
A Phase 1 study of Ulcerative Colitis, sponsored by Landos Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 20
- Study locations
NCT04862741: Completed Phase 1 study of Ulcerative Colitis, sponsored by Landos Biopharma.
NCT04862741 is a Phase 1 study of Ulcerative Colitis that has completed, run by Landos Biopharma. The registered enrollment target is 39 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04862741, a Phase 1 study of Ulcerative Colitis, has completed, sponsored by Landos Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NX-13 250mg IR
- DRUG NX-13 500mg IR
- DRUG NX-13 500mg MR
Study Locations (20)
Florida
- I.H.S Health LLC - Kissimmee
- University of Miami Crohn's and Colitis Center - Miami
- Valencia Medical and Research Center - Miami
- Care Access - Orlando
- Gastroenterology Associates of Pensacola, P.A. - Pensacola
California
- Om Research LLC - Lancaster
- Allameh Medical Corporation - Mission Viejo
- California Medical Research Associates, Inc. - Northridge
- Clinical Research of California - Walnut Creek
Texas
- Avant Research Associates, LLC - Austin
- Biopharma Informatics, LLC - Houston
- LinQ Research, LLC - Pearland
- Southern Star Research Institute, LLC - San Antonio
Alabama
- Avant Research Associates LLC - Huntsville
Georgia
- Atlanta Center for Gastroenterology, P.C. - Decatur
New York
- Care Access - New York
North Carolina
- Care Access - Lumberton
Ohio
- Optimed Research, LTD - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2021-05-05 |
| Est. Completion | 2022-10-05 |
| Phase | Phase 1 |
What the finished NCT04862741 record still lists
NCT04862741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04862741 names 20 study sites across 10 states, led by Florida, California, Texas.
Frequently Asked Questions
What is clinical trial NCT04862741 about?
NCT04862741 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis". 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 subject...
What is the current status of trial NCT04862741?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2021-05-05. Estimated completion is 2022-10-05.
What conditions does trial NCT04862741 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT04862741?
The interventions under investigation include: Placebo (DRUG), NX-13 250mg IR (DRUG), NX-13 500mg IR (DRUG), NX-13 500mg MR (DRUG).
Who is sponsoring clinical trial NCT04862741?
This trial is sponsored by Landos Biopharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04862741 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04862741's enrollment target sits among peer trials
39 96th of 122 higher than 27 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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