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Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04098263
Enrollment
21
Registered
2019-09-23
Start date
2019-11-15
Completion date
2020-06-24
Last updated
2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Campylobacter Jejuni Infection

Brief summary

This will be a randomized, double-blind, placebo-controlled, dose-escalation study of 3 dose levels of LMN-101. Healthy volunteers will take LMN-101 or placebo orally either as a single dose or at one of three dose levels three times daily over 28 days. Protocol-specified evaluations and procedures will be performed on Days 1-2 and every one-two weeks during dosing. Study observation will continue until 4 weeks after the last dose of study drug.

Detailed description

Healthy volunteers will be sequentially assigned to the following dosing regimens: Part A: A single, open-label dose of 3000 mg orally (2 subjects) Part B: Subjects will be randomized within a dose regimen to active or placebo treatment: * 300 mg PO TID (three times daily) given as a single 300-mg capsule of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsule (2 subjects). * 1000 mg PO TID given as two 500-mg capsules of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsules (2 subjects). * 3000 mg PO TID given as six 500-mg capsules of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsules (2 subjects). The primary endpoint is: • Safety and tolerability of LMN-101. The secondary endpoints are: * Peak serum drug concentration following administration of the initial dose and peak serum drug concentration following a course of treatment (if systemic absorption is observed). * Area under the serum drug concentration versus time curve (AUC) following administration of the initial dose and following a course of treatment (if systemic absorption is observed). * Induction of serum anti-drug antibodies (if systemic absorption is observed).

Interventions

BIOLOGICALLMN-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

Sponsors

Lumen Bioscience, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Part B: Identical-appearing placebo

Intervention model description

Part A: Open Label Part B: Randomized, Double-Blind, Placebo-Controlled

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

1. Male or female between 18 and 50 years, inclusive, at time of informed consent 2. Willingness to participate after written informed consent obtained 3. Available for all planned clinical visits for physical examinations, blood draws, stool collections 4. General good health, without significant medical illness or abnormal physical examination findings as determined by the PI. 5. Adequate bone marrow reserve, renal and liver function. 1. Absolute neutrophil count ≥ 1.5 x 10e9/L 2. Lymphocyte count \< 6.0 x 10e9/L 3. Platelet count ≥ 150 x 10e9/L 4. Hemoglobin ≥ 110 g/L 5. Estimated glomerular filtration rate ≥ 40 mL/min/1.73 meter squared 6. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN) 7. Total bilirubin ≤ 1.5x ULN 8. Serum albumin ≥ 28 g/L 6. Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: 1. Sexual abstinence (inactivity) or exclusively same-sex partner for 1 month prior to screening through study completion; or 2. Intrauterine device (IUD) in place for at least 1 month prior to study through study completion; or 3. Stable hormonal contraception for at least 1 month prior to study through study completion; or 4. Surgical sterilization (vasectomy) of male partner at least 6 months prior to study. 7. To be considered of non-childbearing potential, females should be surgically sterilized (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be post-menopausal and at least 3 years since last menses. 8. Male participants must use condoms during the study and through study completion.

Exclusion criteria

1. Treatment with an experimental compound within 30 days. 2. Treatment within 30 days or planned use within the study period with immunomodulator or immunosuppressant agent. 3. Pregnancy or breastfeeding. 4. Presence of any of the following clinical conditions: 1. History of one or more of the following: cardiac insufficiency (NYHA III/IV), uncontrolled cardiac arrhythmias, unstable ischemic heart disease, or uncontrolled hypertension (systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 110 mmHg). 2. History of venous thromboembolic disease within 12 months, myocardial infarction, or cerebrovascular accident. 3. Unstable pulmonary, renal, hepatic, endocrine or hematologic disease. 4. Gastrointestinal disorder requiring ongoing care by a physician. 5. Autoimmune disease, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis. 6. Evidence of active malignant disease, malignancies diagnosed within the previous 5 years, or breast cancer diagnosed within the previous 5 years (except skin cancers other than melanoma). 7. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other opportunistic infections; or major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks. 8. Positive serology for human immunodeficiency virus (HIV) infection or history of other immunodeficiency illness. 9. Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) 10. Significant neuromuscular disease or neuropathy 11. Psychiatric condition 12. Alcohol or illicit drug abuse/dependency or positive urine toxicology screen for drugs of abuse other than marijuana. Alcohol and tobacco consumption are permitted.

Design outcomes

Primary

MeasureTime frameDescription
Count of Participants With Adverse EventsDay 1 to Day 56Counts of participants with adverse events

Countries

Australia

Participant flow

Participants by arm

ArmCount
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
2
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
4
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
5
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
4
Placebo
Placebo identical appearing capsule orally three times daily for 28 days
6
Total21

Baseline characteristics

CharacteristicPart APart B: Cohort 1Part B: Cohort 2Part B: Cohort 3PlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
2 Participants4 Participants5 Participants4 Participants6 Participants21 Participants
Age, Continuous37 years
STANDARD_DEVIATION 4.2
30.3 years
STANDARD_DEVIATION 8.5
32.4 years
STANDARD_DEVIATION 11.8
41 years
STANDARD_DEVIATION 2.6
36.7 years
STANDARD_DEVIATION 9.8
35.3 years
STANDARD_DEVIATION 8.9
Baseline Count of AEs0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2 Participants3 Participants5 Participants3 Participants5 Participants18 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants1 Participants1 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants0 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants1 Participants1 Participants2 Participants
Race (NIH/OMB)
White
2 Participants2 Participants5 Participants3 Participants5 Participants17 Participants
Region of Enrollment
Australia
2 Participants4 Participants5 Participants4 Participants6 Participants21 Participants
Sex: Female, Male
Female
1 Participants3 Participants3 Participants2 Participants5 Participants14 Participants
Sex: Female, Male
Male
1 Participants1 Participants2 Participants2 Participants1 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 20 / 40 / 50 / 40 / 6
other
Total, other adverse events
0 / 21 / 43 / 51 / 43 / 6
serious
Total, serious adverse events
0 / 20 / 40 / 50 / 40 / 6

Outcome results

Primary

Count of Participants With Adverse Events

Counts of participants with adverse events

Time frame: Day 1 to Day 56

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part ACount of Participants With Adverse Events0 Participants
Part B: Cohort 1Count of Participants With Adverse Events1 Participants
Part B: Cohort 2Count of Participants With Adverse Events3 Participants
Part B: Cohort 3Count of Participants With Adverse Events1 Participants
PlaceboCount of Participants With Adverse Events3 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026