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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Experimental |
| |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Experimental |
| |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Experimental |
| |
| Cohort 4 LMN-201 VHH 1, 2, 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMN-201 Anti-toxin B VHH-1 | Biological | Components of LMN-201 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Mason | Lumen Bioscience, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wesley Medical Research Limited | Auchenflower | Queensland | 4066 | Australia | ||
| Coastal Digestive Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 LMN-201 Anti-toxin B VHH-1 | LMN-201 Anti-toxin B VHH-1: Components of LMN-201 |
| FG001 | Cohort 1 LMN-201 Anti-toxin B VHH-2 | LMN-201 Anti-toxin B VHH-2: Components of LMN-201 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 18, 2021 | Feb 7, 2025 |
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| LMN-201 Anti-toxin B VHH-2 |
| Biological |
Components of LMN-201 |
|
| LMN-201 Anti-toxin B VHH-3 | Biological | Components of LMN-201 |
|
| LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3 | Biological | Components of LMN-201 |
|
| Maroochydore |
| Queensland |
| 4558 |
| Australia |
| Coral Sea Clinical Research Institute | North Mackay | Queensland | 4740 | Australia |
| FG002 | Cohort 1 LMN-201 Anti-toxin B VHH-3 | LMN-201 Anti-toxin B VHH-3: Components of LMN-201 |
| FG003 | Cohort 2 LMN-201 VHH 1, 2, 3 | LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3: Components of LMN-201 |
| COMPLETED |
|
| NOT COMPLETED |
|
Adults aged 19 and above with mature ileostomy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 LMN-201 Anti-toxin B VHH-1 | LMN-201 Anti-toxin B VHH-1: Components of LMN-201 |
| BG001 | Cohort 1 LMN-201 Anti-toxin B VHH-2 | LMN-201 Anti-toxin B VHH-2: Components of LMN-201 |
| BG002 | Cohort 1 LMN-201 Anti-toxin B VHH-3 | LMN-201 Anti-toxin B VHH-3: Components of LMN-201 |
| BG003 | Cohort 2 LMN-201 VHH 1, 2, 3 | LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3: Components of LMN-201 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | Count of participants with the presence or absence of capsules and/or transit markers at each collection timepoint in ostomy fluid by visual observation. | Posted | Count of Participants | Participants | Arrival (baseline), Predose (immediately before dosing), and up to 12 hours post dose. |
|
|
|
12 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 LMN-201 Anti-toxin B VHH-1 | LMN-201 Anti-toxin B VHH-1: Components of LMN-201 | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | Cohort 1 LMN-201 Anti-toxin B VHH-2 | LMN-201 Anti-toxin B VHH-2: Components of LMN-201 | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Cohort 1 LMN-201 Anti-toxin B VHH-3 | LMN-201 Anti-toxin B VHH-3: Components of LMN-201 | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Cohort 4 LMN-201 VHH 1, 2, 3 | LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3: Components of LMN-201 | 0 | 6 | 0 | 6 | 1 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA, CTCAE 5.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Director | Lumen Bioscience | 206-899-1904 | trials@lumen.bio |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Pre-dose (immediately before dosing) |
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| 1 hour post-dose |
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| 2 hours post-dose |
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| 3 hours post-dose |
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| 4 hours post-dose |
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| 5 hours post-dose |
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| 6 hours post-dose |
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| 7 hours post-dose |
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| 8 hours post-dose |
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| 9 hours post-dose |
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| 10 hours post-dose |
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| 11 hours post-dose |
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| 12 hours post-dose |
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