NCT06080048

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Sorriso Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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).

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	SOR102	SOR102 capsules
DRUG	Placebo	Matching placebo capsules

Timeline

• Start date: 2023-10-24
• Primary completion: 2024-10-16
• Completion: 2024-11-08
• First posted: 2023-10-12
• Last updated: 2024-11-29

Locations

2 sites across 2 countries: Georgia, Ukraine