Trial Outcomes & Findings for Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies (NCT NCT04893239)
NCT ID: NCT04893239
Last Updated: 2025-03-18
Results Overview
Count of participants with the presence or absence of capsules and/or transit markers at each collection timepoint in ostomy fluid by visual observation.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Arrival (baseline), Predose (immediately before dosing), and up to 12 hours post dose.
Results posted on
2025-03-18
Participant Flow
Participant milestones
| Measure |
Cohort 1 LMN-201 Anti-toxin B VHH-1
LMN-201 Anti-toxin B VHH-1: Components of LMN-201
|
Cohort 1 LMN-201 Anti-toxin B VHH-2
LMN-201 Anti-toxin B VHH-2: Components of LMN-201
|
Cohort 1 LMN-201 Anti-toxin B VHH-3
LMN-201 Anti-toxin B VHH-3: Components of LMN-201
|
Cohort 2 LMN-201 VHH 1, 2, 3
LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3: Components of LMN-201
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
6
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
Baseline characteristics by cohort
| Measure |
Cohort 1 LMN-201 Anti-toxin B VHH-1
n=2 Participants
LMN-201 Anti-toxin B VHH-1: Components of LMN-201
|
Cohort 1 LMN-201 Anti-toxin B VHH-2
n=2 Participants
LMN-201 Anti-toxin B VHH-2: Components of LMN-201
|
Cohort 1 LMN-201 Anti-toxin B VHH-3
n=2 Participants
LMN-201 Anti-toxin B VHH-3: Components of LMN-201
|
Cohort 2 LMN-201 VHH 1, 2, 3
n=6 Participants
LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3: Components of LMN-201
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
63.5 Years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
57.5 Years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
57 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
54.3 Years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
56.8 Years
STANDARD_DEVIATION 10.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cohort 1 LMN-201 Anti-toxin B VHH-1
n=2 Participants
LMN-201 Anti-toxin B VHH-1: Components of LMN-201
|
Cohort 1 LMN-201 Anti-toxin B VHH-2
n=2 Participants
LMN-201 Anti-toxin B VHH-2: Components of LMN-201
|
Cohort 1 LMN-201 Anti-toxin B VHH-3
n=2 Participants
LMN-201 Anti-toxin B VHH-3: Components of LMN-201
|
Cohort 2 LMN-201 VHH 1, 2, 3
n=6 Participants
LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3: Components of LMN-201
|
|---|---|---|---|---|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
Pre-dose (immediately before dosing)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
1 hour post-dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
10 hours post-dose
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
Arrival (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
2 hours post-dose
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
3 hours post-dose
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
4 hours post-dose
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
5 hours post-dose
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
6 hours post-dose
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
7 hours post-dose
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
8 hours post-dose
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
9 hours post-dose
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
11 hours post-dose
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
12 hours post-dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1 LMN-201 Anti-toxin B VHH-1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1 LMN-201 Anti-toxin B VHH-2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1 LMN-201 Anti-toxin B VHH-3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4 LMN-201 VHH 1, 2, 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 LMN-201 Anti-toxin B VHH-1
n=2 participants at risk
LMN-201 Anti-toxin B VHH-1: Components of LMN-201
|
Cohort 1 LMN-201 Anti-toxin B VHH-2
n=2 participants at risk
LMN-201 Anti-toxin B VHH-2: Components of LMN-201
|
Cohort 1 LMN-201 Anti-toxin B VHH-3
n=2 participants at risk
LMN-201 Anti-toxin B VHH-3: Components of LMN-201
|
Cohort 4 LMN-201 VHH 1, 2, 3
n=6 participants at risk
LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3: Components of LMN-201
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/2 • 12 hours
|
0.00%
0/2 • 12 hours
|
0.00%
0/2 • 12 hours
|
16.7%
1/6 • Number of events 1 • 12 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place