Trial Outcomes & Findings for LMN-101 in a Campylobacter Human Challenge Model (NCT NCT04182490)
NCT ID: NCT04182490
Last Updated: 2025-09-25
Results Overview
Number of participants with solicited or unsolicited adverse events that received LMN-101 compared to placebo for the protocol-specified duration of collection for each type of adverse event.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Day 1 to Day 14
Results posted on
2025-09-25
Participant Flow
Participant milestones
| Measure |
3000-mg Cohort
LMN-101, six 500-mg capsules orally three times daily for 14 days (n=21)
LMN-101: VHH-derived binding protein designed to bind and inhibit FlaA, flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, spirulina biomass
|
Placebo Cohort
Placebo, six 500-mg capsules orally three times daily for 14 days (n=21)
Placebo: Identical appearing placebo
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
3000-mg Cohort
LMN-101, six 500-mg capsules orally three times daily for 14 days (n=21)
LMN-101: VHH-derived binding protein designed to bind and inhibit FlaA, flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, spirulina biomass
|
Placebo Cohort
Placebo, six 500-mg capsules orally three times daily for 14 days (n=21)
Placebo: Identical appearing placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
LMN-101 in a Campylobacter Human Challenge Model
Baseline characteristics by cohort
| Measure |
3000-mg Cohort
n=21 Participants
LMN-101, six 500-mg capsules orally three times daily for 14 days (n=21)
LMN-101: VHH-derived binding protein designed to bind and inhibit FlaA, flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, spirulina biomass
|
Placebo Cohort
n=21 Participants
Placebo, six 500-mg capsules orally three times daily for 14 days (n=21)
Placebo: Identical appearing placebo
|
Total
n=42 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
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 7.74 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 9.51 • n=7 Participants
|
33.4 years
STANDARD_DEVIATION 8.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Number of participants with solicited or unsolicited adverse events that received LMN-101 compared to placebo for the protocol-specified duration of collection for each type of adverse event.
Outcome measures
| Measure |
3000-mg Cohort
n=21 Participants
LMN-101, six 500-mg capsules orally three times daily for 14 days (n=21)
LMN-101: VHH-derived binding protein designed to bind and inhibit FlaA, flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, spirulina biomass
|
Placebo Cohort
n=21 Participants
Placebo, six 500-mg capsules orally three times daily for 14 days (n=21)
Placebo: Identical appearing placebo
|
|---|---|---|
|
Number of Participants With Solicited or Unsolicited Adverse Events
Solicited Adverse Events
|
15 Participants
|
16 Participants
|
|
Number of Participants With Solicited or Unsolicited Adverse Events
Unsolicited Adverse Events
|
17 Participants
|
16 Participants
|
Adverse Events
3000-mg Cohort
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo Cohort
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3000-mg Cohort
n=21 participants at risk
LMN-101, six 500-mg capsules orally three times daily for 14 days (n=21)
LMN-101: VHH-derived binding protein designed to bind and inhibit FlaA, flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, spirulina biomass
|
Placebo Cohort
n=21 participants at risk
Placebo, six 500-mg capsules orally three times daily for 14 days (n=21)
Placebo: Identical appearing placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
90.5%
19/21 • Number of events 21 • 59 Days
|
66.7%
14/21 • Number of events 16 • 59 Days
|
|
Gastrointestinal disorders
Abdominal Pain
|
71.4%
15/21 • Number of events 29 • 59 Days
|
66.7%
14/21 • Number of events 23 • 59 Days
|
|
Gastrointestinal disorders
Nausea
|
38.1%
8/21 • Number of events 8 • 59 Days
|
33.3%
7/21 • Number of events 7 • 59 Days
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
4/21 • Number of events 4 • 59 Days
|
4.8%
1/21 • Number of events 1 • 59 Days
|
|
Gastrointestinal disorders
Haematochezia
|
9.5%
2/21 • Number of events 2 • 59 Days
|
4.8%
1/21 • Number of events 1 • 59 Days
|
|
Gastrointestinal disorders
Flatulence
|
9.5%
2/21 • Number of events 2 • 59 Days
|
0.00%
0/21 • 59 Days
|
|
Gastrointestinal disorders
Mucous stools
|
9.5%
2/21 • Number of events 2 • 59 Days
|
0.00%
0/21 • 59 Days
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/21 • 59 Days
|
9.5%
2/21 • Number of events 2 • 59 Days
|
|
Nervous system disorders
Headache
|
71.4%
15/21 • Number of events 21 • 59 Days
|
57.1%
12/21 • Number of events 19 • 59 Days
|
|
General disorders
Chills
|
57.1%
12/21 • Number of events 13 • 59 Days
|
57.1%
12/21 • Number of events 13 • 59 Days
|
|
General disorders
Pyrexia
|
57.1%
12/21 • Number of events 14 • 59 Days
|
38.1%
8/21 • Number of events 8 • 59 Days
|
|
General disorders
Fatigue
|
52.4%
11/21 • Number of events 12 • 59 Days
|
42.9%
9/21 • Number of events 10 • 59 Days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
38.1%
8/21 • Number of events 8 • 59 Days
|
47.6%
10/21 • Number of events 12 • 59 Days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.0%
4/21 • Number of events 5 • 59 Days
|
23.8%
5/21 • Number of events 5 • 59 Days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.0%
4/21 • Number of events 4 • 59 Days
|
14.3%
3/21 • Number of events 3 • 59 Days
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
38.1%
8/21 • Number of events 8 • 59 Days
|
23.8%
5/21 • Number of events 5 • 59 Days
|
|
Cardiac disorders
Tachycardia
|
38.1%
8/21 • Number of events 8 • 59 Days
|
23.8%
5/21 • Number of events 5 • 59 Days
|
|
Investigations
Alanine aminotransferase increased
|
19.0%
4/21 • Number of events 4 • 59 Days
|
0.00%
0/21 • 59 Days
|
|
Investigations
Neutrophil count increased
|
9.5%
2/21 • Number of events 2 • 59 Days
|
4.8%
1/21 • Number of events 1 • 59 Days
|
|
Investigations
Aspartate aminotransferase increased
|
9.5%
2/21 • Number of events 2 • 59 Days
|
0.00%
0/21 • 59 Days
|
|
Investigations
Differential white blood cell count abnormal
|
9.5%
2/21 • Number of events 2 • 59 Days
|
0.00%
0/21 • 59 Days
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
3/21 • Number of events 3 • 59 Days
|
0.00%
0/21 • 59 Days
|
|
Nervous system disorders
Dizzyness
|
23.8%
5/21 • Number of events 5 • 59 Days
|
23.8%
5/21 • Number of events 5 • 59 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place