Back to resultsA Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
SOR102
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
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.
Sites / Locations
- MAC Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Single Ascending Doses Cohorts 1-4 Part 1, SOR102
Single Ascending Doses Cohorts 1-4 Part 1, Placebo
Multiple Doses Part 2, SOR102
Multiple Doses Part 2, Placebo
Arm Description
SOR102, Single dose Single dose of SOR102, oral capsules
Placebo matched to SOR102, oral capsules
Multiple doses of SOR102, 7 days, 1 dose level BID, oral capsule
Placebo matched to SOR102, oral capsule
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT06080048
First Posted
October 6, 2023
Last Updated
October 6, 2023
Sponsor
Sorriso Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT06080048
Brief Title
A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorriso Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Ascending Doses Cohorts 1-4 Part 1, SOR102
Arm Type
Experimental
Arm Description
SOR102, Single dose Single dose of SOR102, oral capsules
Arm Title
Single Ascending Doses Cohorts 1-4 Part 1, Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matched to SOR102, oral capsules
Arm Title
Multiple Doses Part 2, SOR102
Arm Type
Experimental
Arm Description
Multiple doses of SOR102, 7 days, 1 dose level BID, oral capsule
Arm Title
Multiple Doses Part 2, Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matched to SOR102, oral capsule
Intervention Type
Drug
Intervention Name(s)
SOR102
Intervention Description
SOR102 capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules
Primary Outcome Measure Information:
Title
Treatment Emergent Adverse Events following oral dosing
Description
After single ascending oral doses, number of subjects with AEs in the SOR102 dose level cohorts compared with the oral placebo group
Time Frame
Up to 11 days post dose in Part 1
Title
Treatment Emergent Adverse Events following oral dosing
Description
After multiple oral doses administered BID, number of subjects with AEs in the SOR102 dose level cohorts compared with the oral placebo group
Time Frame
Up to 21 days post dose in Part 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Wedel
Phone
(385) 342-4989
Email
pwedel@sorrisopharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Sattler, MD
Email
csattler@sorrisopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos C Sattler, MD
Organizational Affiliation
Sorriso Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
MAC Clinical Research
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis
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