Study to Investigate the Safety, Tolerability and Pharmacokinetics of SOR102 in Healthy Adults.
Research type
Research Study
Full 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
IRAS ID
1007559
Contact name
Pamela Wedel
Contact email
Sponsor organisation
Sorriso Pharmaceuticals, Inc.
Eudract number
2023-000219-33
Research summary
This study aims to assess the safety and tolerability of an investigational (study) drug called SOR102 and to see how the body absorbs and removes the drug. SOR102 was developed by Sorriso Pharmaceuticals to treat ulcerative colitis (UC). UC is a chronic condition causing severe diarrhea, stomach pain, and frequent need to pass stool. There is currently no cure for UC. Options are available to help manage symptoms but are not effective for everyone. It is thought that SOR102 might be able to treat UC in two different ways at once and increase the chances of an effective response to treatment for patients.
This study consists of 3 parts. Part 1 will be the first time the SOR102 will be given to humans; it will be given as a single dose on one day. Part 2 will be the first time SOR102 has been given to humans over multiple dosing days. In Part 3, SOR102 will be given twice per day for a period of 42 days. Participants in Parts 1 & 2 will be healthy volunteers. Part 3 participants will have mild to moderate active UC.
All participants will be randomized (assigned by chance, like flipping a coin) to receive study drug or placebo. This is a double‑blinded study, meaning neither the participants nor the study doctor will know who is given study drug or placebo.
Part 1 participants will be in the study for about 6 weeks; Part 2 for 8 weeks, and Part 3 for 12 weeks. Part 1 participants will be given the study drug once. Part 2 participants will be given the study drug twice daily for 7 days. Part 3 participants will be given the study drug for 42 consecutive days. Participation in Parts 1 & 2 will consist of 3 study visits including a screening visit to assess eligibility, an inpatient stay, and a follow up visit. Participants in Part 3 will be required to attend 10 study visits including a screening visit, 6 clinic visits, 2 sigmoidoscopy visits, 3 telephone call visits, and a Follow-up visit. Parts 1 & 2 will be at MAC Manchester; location for Part 3 is TBC.REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0244
Date of REC Opinion
29 Sep 2023
REC opinion
Further Information Favourable Opinion