LIV001 in Patients with Mild-to-Moderate Active Ulcerativ... | NCT06749795

Studies
LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)

NCT06749795

Sponsor

Liveome Inc.

Status

Not yet recruiting

Last Update Posted

Mar 24, 2025Actual

Enrollment

15Estimated

Phase

Phase 1

Conditions

Ulcerative Colitis (UC)

Interventions

LIV001
Placebo

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 24, 2025Estimated

Primary Completion Date

Jan 17, 2026Estimated

Completion Date

Mar 24, 2026Estimated

First Submitted Date

Dec 17, 2024

First Submission Date that Met QC Criteria

Dec 23, 2024

First Posted Date

Dec 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2025

Last Update Posted Date

Mar 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis

Detailed Description

A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of LIV001 in patients with mild to moderate UC. Patients will receive LIV001 or placebo for 8 weeks. All patients will return to the site for a follow-up visit on week 12.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LIV001	Experimental	LIV001 will be given orally and daily from baseline until end of study	Drug: LIV001
Placebo	Placebo Comparator	Placebo will be given orally and daily from baseline until end of study	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LIV001	Drug	Orally administered for 8 weeks	LIV001
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects with adverse events (AEs)		Baseline through Study Completion (Week 12).
Number of subjects with clinical laboratory abnormalities		Baseline through Study Completion (Week 12).
Number of subjects with changes in the 12-lead electrocardiogram (ECG)		Baseline through Study Completion (Week 12).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female aged 18 to 65 years (inclusive) at Screening.
Established diagnosis of UC for at least 3 months prior to Screening, diagnosed by routine clinical, radiographic, endoscopic or pathologic criteria (Confirmed by colonoscopy and pathology records or, if unavailable, diagnosis confirmed by a letter from the subject's general practitioner.)

Exclusion Criteria:

Possible or confirmed diagnosis of Crohn's Disease, other form of inflammatory bowel disorder and coeliac disease.
History of a condition associated with significant immunosuppression, or chronic administration (> 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to Visit 3 (subjects taking oral medications for UC, including corticosteroids or immunomodulators, are not excluded).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sophie Hyun-Ja Ko, Doctor of Philosophy	Contact	+82-31-8065-8216		sophieko@liveome.co.kr

Overall Officials

Name	Affiliation	Role
Piotr Napora, Doctor of Medicine	Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska		Wroclaw			Poland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided