Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies

February 27, 2025 updated by: Lumen Bioscience, Inc.
This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Wesley Medical Research Limited
      • Maroochydore, Queensland, Australia, 4558
        • Coastal Digestive Health
      • North Mackay, Queensland, Australia, 4740
        • Coral Sea Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Willing to participate in the clinical trial
  • Able and willing to provide informed consent
  • Stable ostomy (no revisions in the last 6 months)
  • At least 19 years old
  • Medically stable, but may be on medications for chronic conditions

Exclusion Criteria:

  • Unable or unwilling to provide adequate informed consent
  • Non-English speakers
  • Clinically significant disease
  • Women who are pregnant, intending to become pregnant, or breastfeeding
  • Use of anti-diarrheal medicine
  • Suffer gastroparesis
  • Opioid use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 LMN-201 Anti-toxin B VHH-1
Biological: LMN-201 Anti-toxin B VHH-1
Components of LMN-201
Experimental: Cohort 1 LMN-201 Anti-toxin B VHH-2
Biological: LMN-201 Anti-toxin B VHH-2
Components of LMN-201
Experimental: Cohort 1 LMN-201 Anti-toxin B VHH-3
Biological: LMN-201 Anti-toxin B VHH-3
Components of LMN-201
Experimental: Cohort 4 LMN-201 VHH 1, 2, 3
Biological: LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3
Components of LMN-201

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
Time Frame: Arrival (baseline), Predose (immediately before dosing), and up to 12 hours post dose.
Count of participants with the presence or absence of capsules and/or transit markers at each collection timepoint in ostomy fluid by visual observation.
Arrival (baseline), Predose (immediately before dosing), and up to 12 hours post dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumen Bioscience, Inc.

Investigators

  • Study Director: Carl Mason, Lumen Bioscience, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2021

Primary Completion (Actual)

February 23, 2022

Study Completion (Actual)

February 23, 2022

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

May 14, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDI01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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