A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis

Last updated: November 26, 2024
Sponsor: Sorriso Pharmaceuticals, Inc.
Overall Status: Completed

Phase

1

Condition

Inflammatory Bowel Disease

Ulcers

Ulcerative Colitis

Treatment

SOR102

Placebo

Clinical Study ID

NCT06080048
SOR102-101
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or females, of any ethnic origin.

  • Established diagnosis of UC by standard criteria for >3 months.

  • Disease evaluable by sigmoidoscopy.

  • Mildly to severely active UC as determined by central reader in combination withother assessments of disease

Exclusion

Key Exclusion Criteria:

  • Any diagnosis of IBD except for UC.

  • History of fistula(e), strictures or surgery, known intestinal obstruction, ordiagnosis of toxic megacolon.

  • Concurrent use of any biologic drug.

  • Prior primary efficacy failure or secondary loss of response to more than onebiologic or new small molecule therapy (i.e., JAK inhibitors or S1P receptormodulators) indicated for the treatment of UC. This does not include priordiscontinuation due to drug intolerance.

Study Design

Total Participants: 22
Treatment Group(s): 2
Primary Treatment: SOR102
Phase: 1
Study Start date:
October 24, 2023
Estimated Completion Date:
November 08, 2024

Connect with a study center

  • Arensia Exploratory Medicine

    Tbilisi,
    Georgia

    Site Not Available

  • Arensia Exploratory Medicine

    Kyiv,
    Ukraine

    Site Not Available

  • MAC Clinical Research

    Manchester,
    United Kingdom

    Site Not Available

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