Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis

PHASE1CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

May 5, 2021

Primary Completion Date

June 17, 2022

Study Completion Date

October 5, 2022

Conditions
Ulcerative Colitis
Interventions
DRUG

NX-13 250mg IR

Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.

DRUG

NX-13 500mg IR

Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.

DRUG

NX-13 500mg MR

Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.

DRUG

Placebo

Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.

Trial Locations (31)

10002

Communal Non-commercial Enterprise O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council, Zhytomyr

10065

Care Access, New York

17901

Care Access, Pottsville

21018

Communal Non-Commercial Enterprise of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council, Vinnytsia

21029

Communal Non-commercial Enterprise Vinnytsia City Clinical Hospital #1, Department of Gastroenterology, Vinnytsia

28538

Care Access, Lumberton

30033

Atlanta Center for Gastroenterology, P.C., Decatur

32503

Gastroenterology Associates of Pensacola, P.A., Pensacola

32825

Care Access, Orlando

33136

University of Miami Crohn's and Colitis Center, Miami

33165

Valencia Medical and Research Center, Miami

34741

I.H.S Health LLC, Kissimmee

35802

Avant Research Associates LLC, Huntsville

37404

Galen Medical Group, Chattanooga

43235

Optimed Research, LTD, Columbus

49005

Communal Enterprise I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital of Dnipropetrovsk Regional Counsil, cont., Dnipro

69121

Medical Center of Limited Liability Company Gastroenterology Center IBD TEAM, Zaporizhzhya

76008

Communal Non-commercial Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council, Ivano-Frankivsk

77084

Biopharma Informatics, LLC, Houston

77584

LinQ Research, LLC, Pearland

77904

Victoria Gastroenterology, Victoria

78229

Southern Star Research Institute, LLC, San Antonio

78742

Avant Research Associates, LLC, Austin

84124

Care Access Research, Salt Lake City, Salt Lake City

91324

California Medical Research Associates, Inc., Northridge

92691

Allameh Medical Corporation, Mission Viejo

93534

Om Research LLC, Lancaster

94598

Clinical Research of California, Walnut Creek

02091

"Medical Center 'Ok!Clinic+' of Copmany with limited liability International institue of Clinical Research", Kyiv

03143

"Clinical Hospital Feofaniya of State Management of Affairs, Center of Gastroenterology and Endocrinology", Kyiv

04078

Communal Non-commercial Enterprise of Kyiv Regional Council Kyiv Regional Hospital, Department of Therapy, Kyiv

Sponsors
All Listed Sponsors
lead

Landos Biopharma Inc.

INDUSTRY