C. Diff. Infections
Conditions
Brief summary
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.
Interventions
BIOLOGICALLMN-201 Anti-toxin B VHH-1
Components of LMN-201
BIOLOGICALLMN-201 Anti-toxin B VHH-2
Components of LMN-201
BIOLOGICALLMN-201 Anti-toxin B VHH-3
Components of LMN-201
BIOLOGICALLMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3
Components of LMN-201
Sponsors
Lumen Bioscience, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 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. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 LMN-201 Anti-toxin B VHH-1 LMN-201 Anti-toxin B VHH-1: Components of LMN-201 | 2 |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 LMN-201 Anti-toxin B VHH-2: Components of LMN-201 | 2 |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 LMN-201 Anti-toxin B VHH-3: Components of LMN-201 | 2 |
| Cohort 2 LMN-201 VHH 1, 2, 3 LMN-201 Anti-toxin B VHH-1, VHH-2, VHH-3: Components of LMN-201 | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Cohort 2 LMN-201 VHH 1, 2, 3 | Total | Cohort 1 LMN-201 Anti-toxin B VHH-1 | Cohort 1 LMN-201 Anti-toxin B VHH-2 | Cohort 1 LMN-201 Anti-toxin B VHH-3 |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 12 Participants | 2 Participants | 2 Participants | 2 Participants |
| Age, Continuous | 54.3 Years STANDARD_DEVIATION 12.1 | 56.8 Years STANDARD_DEVIATION 10.4 | 63.5 Years STANDARD_DEVIATION 13.4 | 57.5 Years STANDARD_DEVIATION 3.5 | 57 Years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 12 Participants | 2 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 12 Participants | 2 Participants | 2 Participants | 2 Participants |
| Region of Enrollment Australia | 6 Participants | 12 Participants | 2 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 6 |
| other Total, other adverse events | 0 / 2 | 0 / 2 | 0 / 2 | 1 / 6 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 6 |
Outcome results
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.
Time frame: Arrival (baseline), Predose (immediately before dosing), and up to 12 hours post dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 7 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 6 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 3 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 12 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 5 hours post-dose | 2 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 4 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 10 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | Arrival (Baseline) | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 1 hour post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 11 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 9 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 8 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 2 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-1 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | Pre-dose (immediately before dosing) | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 9 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | Arrival (Baseline) | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | Pre-dose (immediately before dosing) | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 1 hour post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 2 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 3 hours post-dose | 2 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 4 hours post-dose | 2 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 5 hours post-dose | 2 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 6 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 7 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 8 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 10 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 11 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-2 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 12 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 9 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 11 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | Pre-dose (immediately before dosing) | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 2 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 10 hours post-dose | 2 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | Arrival (Baseline) | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 8 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 6 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 4 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 1 hour post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 3 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 12 hours post-dose | 0 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 5 hours post-dose | 1 Participants |
| Cohort 1 LMN-201 Anti-toxin B VHH-3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 7 hours post-dose | 2 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 5 hours post-dose | 2 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 6 hours post-dose | 4 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 11 hours post-dose | 0 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 7 hours post-dose | 3 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 1 hour post-dose | 0 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 8 hours post-dose | 3 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | Pre-dose (immediately before dosing) | 0 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 9 hours post-dose | 1 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 12 hours post-dose | 0 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 10 hours post-dose | 0 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 3 hours post-dose | 3 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | Arrival (Baseline) | 0 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 4 hours post-dose | 4 Participants |
| Cohort 2 LMN-201 VHH 1, 2, 3 | Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation | 2 hours post-dose | 0 Participants |