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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 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.

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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.

Conditions Studied

Ulcerative Colitis

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

FieldValue
Enrollment Target 39 participants
Start Date 2021-05-05
Est. Completion 2022-10-05
Phase Phase 1

Sponsor

Landos Biopharma

1 total trials

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What the Registry Record Tells You About NCT04862741

The ClinicalTrials.gov registry entry for NCT04862741 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The listed sponsor is Landos Biopharma, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.