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

Ulcerative Colitis Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080048
• Other study ID #: SOR102-101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 24, 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Sorriso Pharmaceuticals, Inc.
• Contact: Pamela Wedel
• Phone: (385) 342-4989
• Email: pwedel[@]sorrisopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• SOR102
SOR102 capsules
• Placebo
Matching placebo capsules

Locations

Country	Name	City	State
Georgia	Arensia Exploratory Medicine	Tbilisi
Ukraine	Arensia Exploratory Medicine	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Sorriso Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Georgia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 6 weeks in Part 3 or at the time of study discontinuation
Secondary	SOR102 concentrations following oral dosing	To determine the concentration of SOR102 in serum, urine and feces.	Up to 6 weeks in Part 3 or at the time of study discontinuation
Secondary	Incidence of positive ADAs to SOR102	To assess the incidence of positive ADAs to SOR102.	Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation
Secondary	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.	Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation