Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Following screening period (up to 28 days in length), a total of 40 subjects are planned to
      be enrolled into this study from multiple sites in the United States, Australia, New Zealand,
      and Moldova. Eligible 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) or placebo via a
      computer-generated interactive web response system (IWRS). Each of the NX-13 treatment groups
      will comprise 12 subjects and 4 subjects will be randomized to receive placebo. The study
      will include a maximum of 25% of subjects who have had prior exposure to biologic therapy for
      UC.

      Dosing will extend over a 28-day period at each dose level. Subjects will receive the first
      dose of study drug in clinic on Day 1 (Visit 2) and Day 28 (Visit 4/EOT) but will
      self-administer IP at home once daily for the remaining dosing days. The study duration will
      be approximately 63 days: Screening Period (28 days) + Treatment Period (28 days) + Safety
      Follow-up (7 days after last dose). There will be a follow-up visit on Day 35 (Visit 5).
    

Intervention name(s): NX-13 250mg IR; NX-13 500mg IR; NX-13 500mg MR; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment