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
Clinicaltrials.gov Identifier
Research summary
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.Lay summary of results:
Ulcerative colitis (UC) is a disease where the large intestine & rectum can have swelling & ulcers (sores). People with UC often have bloody stools, cramps, and diarrhea & often don’t feel well. There are times when symptoms are very bad, called flares & times when there are few to no symptoms, called remission. While many drugs exist to treat UC, no single drug works for everyone.
Sorriso Pharmaceuticals is developing SOR102, which is an investigational drug being studied to determine whether it can help people with UC. “Investigational” means that it has not been approved & is still being tested for its safety & effectiveness. SOR102 comes in a pill that is swallowed & the SOR102 works inside your large intestine & is thought to help reduce inflammation.
Primary Objective: Does SOR102 have any side effects when given to participants with UC? Primary Endpoint: Researchers tracked all side effects that happened during the trial. They looked at the results of different tests & measurements to see if there were changes to the participants’ health after receiving SOR102, both for taking a single dose or multiple doses.
Secondary Objective: How is SOR102 absorbed & cleared from the body, how does it work, & how does the immune system respond to it? Secondary Endpoint: Blood, stool & urine samples were collected from participants & tested at different laboratories. At the end of the study, researchers compared the test results from participants who received different doses of SOR102 versus placebo, a solution that looks the same as SOR102 but has no active ingredient.
The study had 3 parts. The study included groups that received different doses of SOR102 & a group that received a placebo. Each group had at least 6 participants, who were randomized to receive SOR102 or placebo. Randomized means that a computer program randomly assigned participants to either SOR102 or placebo. The study was double-blind, which means that neither the participants nor the researchers knew if SOR102 or placebo was being given to the participant. Participants were entered (enrolled) into each group one after the other. Before the next group could begin their treatment, doctors reviewed the information collected from participants in the previous group & gave their advice on how to continue the study.
The study began on 09Oct2023 & ended on 16Oct2024. Each participant was involved in the study for up to 12 weeks, depending on what part of the study they were in. This included a 4-week screening period & a 1- to 6-week treatment period. After the treatment period, participants had a safety follow up period for 2 weeks after the last dose of SOR102. The study screened 157 participants in 3 sites across 3 countries (United Kingdom, Ukraine, and Georgia). A total of 64 participants were randomized across 3 sites. 48 participants received SOR102 & 16 received placebo. Participants in the study were either healthy volunteers or had UC & were between the ages of 18 to 75 years. There were more male participants than female participants. A total of 64 participants received treatment, 59 out of 64 & completed the study; 5 participants did not complete the study. Two participants were noncompliant with the study schedule, 1 participant withdrew consent, & 2 participants had worsening of UC.
In Part 1 of the study, there were 5 unrelated side effects (2 events of menstrual problems, 1 event each of gas, headache, & catheter site pain from a blood draw) & 1 related side effect (diarrhea) that was mild. In Part 2, there were no reported side effects. In Part 3 of the study, side effects were reported in 44% of patients who received SOR102 & 50% of patients who received placebo; of these were mild-to-moderate in severity. One side effect was considered possibly related to SOR102 (abdominal pain of mild severity); this participant also had a worsening of UC that led to hospitalization. This was considered not related to SOR102. The study doctors did not think there were any meaningful safety problems in the study. All side effects were treated before the end of the study. No participants died during the study.
The amount of SOR102 in faeces was directly related to the dose the participants received & these analyses also showed that SOR102 stays in the digestive system & was only present in tiny amounts in blood or urine.
To see how SOR102 affects the body, researchers looked for changes in the number of different immune cell populations (how it affects your immune system). Anti-drug antibodies (ADAs) are proteins created by the immune system to fight against foreign substances. Researchers looked for ADAs because they can decrease how well a drug works. It was discovered that the number of participants who had ADAs in their blood was more common in participants who received more doses of SOR102. There was not any pattern between the presence of these ADAs & safety or if the drug was effective.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