Trial Outcomes & Findings for Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers (NCT NCT04098263)

NCT ID: NCT04098263

Last Updated: 2025-02-04

Results Overview

Counts of participants with adverse events

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

21 participants

Primary outcome timeframe

Day 1 to Day 56

Results posted on

2025-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Part A 3000 mg PO single dose given as six 500-mg capsules of LMN-101 orally LMN-101: variable heavy chain-derived binding protein designed to bind and inhibit flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, encapsulated spirulina biomass	Part B: Cohort 1 300 mg PO TID given as a single 300-mg capsule of LMN-101 orally three times daily for 28 days LMN-101: variable heavy chain-derived binding protein designed to bind and inhibit flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, encapsulated spirulina biomass	Part B: Cohort 2 1000 mg PO TID given as two 500-mg capsules of LMN-101 orally three times daily for 28 days LMN-101: variable heavy chain-derived binding protein designed to bind and inhibit flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, encapsulated spirulina biomass	Part B: Cohort 3 3000 mg PO TID given as six 500-mg capsules of LMN-101 orally three times daily for 28 days LMN-101: variable heavy chain-derived binding protein designed to bind and inhibit flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, encapsulated spirulina biomass	Placebo Placebo group
Overall Study STARTED	2	4	5	4	6
Overall Study COMPLETED	2	4	4	4	6
Overall Study NOT COMPLETED	0	0	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part B: Cohort 3 n=4 Participants 3000 mg PO TID given as six 500-mg capsules of LMN-101 orally three times daily for 28 days LMN-101: variable heavy chain-derived binding protein designed to bind and inhibit flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, encapsulated spirulina biomass	Placebo n=6 Participants Placebo identical appearing capsule orally three times daily for 28 days	Total n=21 Participants Total of all reporting groups	Part A n=2 Participants 3000 mg PO single dose given as six 500-mg capsules of LMN-101 orally LMN-101: variable heavy chain-derived binding protein designed to bind and inhibit flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, encapsulated spirulina biomass	Part B: Cohort 1 n=4 Participants 300 mg PO TID given as a single 300-mg capsule of LMN-101 orally three times daily for 28 days LMN-101: variable heavy chain-derived binding protein designed to bind and inhibit flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, encapsulated spirulina biomass	Part B: Cohort 2 n=5 Participants 1000 mg PO TID given as two 500-mg capsules of LMN-101 orally three times daily for 28 days LMN-101: variable heavy chain-derived binding protein designed to bind and inhibit flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, encapsulated spirulina biomass
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	6 Participants n=21 Participants	21 Participants n=8 Participants	2 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	41 years STANDARD_DEVIATION 2.6 • n=4 Participants	36.7 years STANDARD_DEVIATION 9.8 • n=21 Participants	35.3 years STANDARD_DEVIATION 8.9 • n=8 Participants	37 years STANDARD_DEVIATION 4.2 • n=5 Participants	30.3 years STANDARD_DEVIATION 8.5 • n=7 Participants	32.4 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=4 Participants	5 Participants n=21 Participants	14 Participants n=8 Participants	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=4 Participants	1 Participants n=21 Participants	7 Participants n=8 Participants	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=4 Participants	5 Participants n=21 Participants	18 Participants n=8 Participants	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=4 Participants	5 Participants n=21 Participants	17 Participants n=8 Participants	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Australia	4 Participants n=4 Participants	6 Participants n=21 Participants	21 Participants n=8 Participants	2 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Baseline Count of AEs	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 56

Counts of participants with adverse events