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

NCT ID: NCT06080048

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2024-11-08

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 severe UC (Part 3).

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part 3 SOR102 QD

SOR102 once a day for 6 weeks SOR102 oral capsules

Group Type EXPERIMENTAL

SOR102

Intervention Type DRUG

SOR102 capsules

Part 3 SOR102 BID

SOR102 twice a day for 6 weeks SOR102 oral capsules

Group Type EXPERIMENTAL

SOR102

Intervention Type DRUG

SOR102 capsules

Part 3 Placebo

Placebo for twice a day for 6 weeks Placebo oral capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsules

Interventions

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SOR102

SOR102 capsules

Intervention Type DRUG

Placebo

Matching placebo capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or females, of any ethnic origin.
* Established diagnosis of UC by standard criteria for \>3 months.
* Disease evaluable by sigmoidoscopy.
* Mildly to severely active UC as determined by central reader in combination with other assessments of disease

Exclusion Criteria

* Any diagnosis of IBD except for UC.
* History of fistula(e), strictures or surgery, known intestinal obstruction, or diagnosis of toxic megacolon.
* Concurrent use of any biologic drug.
* Prior primary efficacy failure or secondary loss of response to more than one biologic or new small molecule therapy (i.e., JAK inhibitors or S1P receptor modulators) indicated for the treatment of UC. This does not include prior discontinuation due to drug intolerance.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sorriso Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos C Sattler, MD

Role: STUDY_DIRECTOR

Sorriso Pharmaceuticals

Locations

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Arensia Exploratory Medicine

Tbilisi, , Georgia

Site Status

Arensia Exploratory Medicine

Kyiv, , Ukraine

Site Status

Countries

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Georgia Ukraine

Other Identifiers

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SOR102-101

Identifier Type: -

Identifier Source: org_study_id