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

Study Overview
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Brief Summary
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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 moderate UC (Part 3). The details provided describe Parts 1 and 2 of the study. This post will be updated to describe Part 3 once Parts 1 and 2 are completed.

Official Title
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A Phase I Randomised Double-Blind First-in-Human Single Ascending Dose and Multiple Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of SOR102 in Healthy Adult Participants and Patient Volunteers With Mild to Moderate Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: SOR102
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male or females, of any ethnic origin between the ages of 18 to 55 years Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive. Healthy as determined by a responsible physician Normal bowel habits as defined by usual passage of daily stool. Key Exclusion Criteria: Clinically relevant history of abnormal physical or mental health interfering with the study Clinically relevant abnormal laboratory results History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug. Any other concomitant disease or condition that could interfere with the conduct of the study. Participant has veins unsuitable for venepuncture and/or cannulation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Ascending Doses Cohorts 1-4 Part 1, SOR102<br>SOR102, Single dose Single dose of SOR102, oral capsules | Drug: SOR102<br>* SOR102 capsules<br>Drug: Placebo<br>* Matching placebo capsules<br>|
| Placebo Comparator: Single Ascending Doses Cohorts 1-4 Part 1, Placebo<br>Placebo matched to SOR102, oral capsules | Drug: SOR102<br>* SOR102 capsules<br>Drug: Placebo<br>* Matching placebo capsules<br>|
| Experimental: Multiple Doses Part 2, SOR102<br>Multiple doses of SOR102, 7 days, 1 dose level BID, oral capsule | Drug: SOR102<br>* SOR102 capsules<br>Drug: Placebo<br>* Matching placebo capsules<br>|
| Placebo Comparator: Multiple Doses Part 2, Placebo<br>Placebo matched to SOR102, oral capsule | Drug: SOR102<br>* SOR102 capsules<br>Drug: Placebo<br>* Matching placebo capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Adverse Events following oral dosing | After single ascending oral doses, number of subjects with AEs in the SOR102 dose level cohorts compared with the oral placebo group | Up to 11 days post dose in Part 1 | 
| Treatment Emergent Adverse Events following oral dosing | After multiple oral doses administered BID, number of subjects with AEs in the SOR102 dose level cohorts compared with the oral placebo group | Up to 21 days post dose in Part 2 |