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Completed

NCT Number: NCT06080048

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

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).

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arensia Exploratory Medicine, Tbilisi, Georgia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 with other assessments of disease

Key Exclusion Criteria:

  • Any diagnosis of IBD except for UC.
  • History of fistula(e), strictures or surgery, known intestinal obstruction, or diagnosis of toxic megacolon.
  • Concurrent use of any biologic drug.
  • Prior primary efficacy failure or secondary loss of response to more than one biologic or new small molecule therapy (i.e., JAK inhibitors or S1P receptor modulators) indicated for the treatment of UC. This does not include prior discontinuation due to drug intolerance.

Treatment and study plan

SOR102

Drug

SOR102 capsules

Placebo

Drug

Matching placebo capsules

Primary outcomes

  1. Treatment Emergent Adverse Events following oral dosing

    Time frame: Up to 6 weeks in Part 3 or at the time of study discontinuation

    After multiple oral doses administered BID or QD, number of subjects with AEs in the SOR102 dose level cohorts compared with the oral placebo group

Secondary outcomes

  1. SOR102 concentrations following oral dosing

    Time frame: Up to 6 weeks in Part 3 or at the time of study discontinuation

    To determine the concentration of SOR102 in serum, urine and feces.

  2. Incidence of positive ADAs to SOR102

    Time frame: Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation

    To assess the incidence of positive ADAs to SOR102.

  3. Incidence of positive neutralizing ADA

    Time frame: Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation

    To assess the incidence of positive neutralizing ADA to SOR102 and its monomers in patients with positive ADA to SOR102.

Sponsors and collaborators

Lead sponsor

Sorriso Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Ph I Randomized Double-Blind First-in-Human Single Ascending Dose & Multiple Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of SOR102 in Healthy Adult Participants and Patient Volunteers With Mild to Severe Ulcerative Colitis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2023
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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