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

Sorriso Pharmaceuticals, Inc.22 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Ulcerative Colitis

Interventions

SOR102DRUG

SOR102 capsules

PlaceboDRUG

Matching placebo capsules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Arensia Exploratory Medicine

Tbilisi, Georgia

Arensia Exploratory Medicine

Kyiv, Ukraine

Outcomes

Primary Outcomes

Treatment Emergent Adverse Events following oral dosing

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

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

Secondary Outcomes

SOR102 concentrations following oral dosing

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

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

Incidence of positive ADAs to SOR102

To assess the incidence of positive ADAs to SOR102.

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

Incidence of positive neutralizing ADA

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

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

Data from ClinicalTrials.gov

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