LMN-101 in a Campylobacter Human Challenge Model

Inclusion Criteria

1. Male or non-pregnant female between 18 and 50 years of age, inclusive, at time of informed consent

2. Willingness to participate after written informed consent obtained

3. Available for all planned follow-up visits and anticipated to remain available for clinic visits (for examination, blood draws and stool collection) and follow-up monitoring (90 days post-challenge and by phone for 182 days post-challenge)

4. Demonstrated comprehension of the protocol procedures including knowledge of campylobacter illness by passing a written examination (passing grade ≥ 70%)

5. Willingness to ingest LMN-101 or placebo capsules 3 times a day for 28 days

6. General good health, without significant medical illness, abnormal physical examination findings or clinically significant laboratory abnormalities, as determined by the Principal Investigator (PI; may consult with the Medical Monitor on a case-by-case basis)

7. Adequate bone marrow reserve, renal and liver function:

1. Absolute neutrophil count ≥ 1225/µL

2. Lymphocyte count ≥ 750/µL

3. Platelet count ≥ 125,000/µL

4. Hemoglobin ≥ 11 g/dL in males (>10.5 g/dL in females)

5. Serum creatinine ≤1.7x upper limit of normal (ULN)

6. ALT and/or AST ≤ 3x ULN

7. Total bilirubin ≤ 1.5x ULN

8. Females of childbearing potential should be using and committed to continue one of the following acceptable birth control methods consistently for at least 1 month prior to screening through study completion:

1. Sexual abstinence (inactivity); or

2. Condoms with spermicide; or

3. Diaphragm with spermicide,

4. Intrauterine device (IUD); or

5. Stable hormonal contraception; or

6. Surgical sterilization (vasectomy) of male partner at least 6 months prior to study.

9. 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 1 year since last menses.

Exclusion Criteria:

General health/issues

1. Presence of a significant medical condition (e.g., psychiatric condition; gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis/dyspepsia, inflammatory bowel disease, irritable bowel syndrome (as defined by the Rome III criteria or medical diagnosis); alcohol or illicit drug abuse/dependency) or laboratory abnormalities which in the opinion of the Principal Investigator preclude participation in the study

2. Positive serology results for HIV, HBsAg, or HCV with confirmatory assays

3. Positive urine toxicology screen for opioids, benzodiazepines or amphetamines

4. Significant abnormalities in screening laboratory hematology or serum chemistry, as determined by PI or PI in consultation with the Medical Monitor

5. Use of any medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding receipt of the challenge inoculum or planned to be used during the active study period

6. Pregnancy or breastfeeding Study-specific exclusionary conditions based on potential increased risk or complicating outcome ascertainment

7. Personal or documented family history of Guillain-Barré syndrome or neuromuscular disease; or an inflammatory arthritis such as reactive arthritis, Reiter's syndrome, ankylosing spondylitis, or rheumatoid arthritis (not including osteoarthritis or vague history of arthritis relatively late in adulthood)

8. Evidence of neurological abnormalities

9. Evidence of inflammatory arthritis on exam

10. Fever within the 2 weeks prior to time of enrollment

11. Evidence of IgA deficiency (serum IgA < 7 mg/dL or below the limit of detection of assay)

12. HLA-B27 positive (flow cytometry)

13. Allergy or prior intolerance to two or more of the following antibiotics: azithromycin, ciprofloxacin, levofloxacin, erythromycin, doxycycline, ampicillin, or amoxicillin-clavulanate

14. Fewer than 3 stools per week or more than 3 stools per day as the usual frequency

15. History of moderate to serious diarrhea while traveling in a developing country within the last 3 years

16. Regular use of antidiarrheal, antacids, loperamide, bismuth subsalicylate diphenoxylate or similar medication (regular defined as at least weekly)

17. Use of proton pump inhibitors, H2 blockers, or other antacids within 48 hours preceding initiation of LMN-101 or placebo

18. Use of antibiotics during the 7 days preceding initiation of LMN-101 or placebo

19. Use of spirulina other than the study drug in the 30 days preceding initiation of LMN-101 or placebo

20. Use of any investigational product within 30 days preceding initiation of LMN-101 or placebo or planned use during the active study period

21. Use of any medication known to affect the immune system (e.g., systemic corticosteroids) within 30 days preceding initiation of LMN-101 or placebo or planned use during the active study period (excluding inhaled steroids with spacer)

22. History of prior exposure to campylobacter including by vaccination or infection in previous trials, or serum immunoglobulin A (IgA) titer to C. jejuni CG8421 glycine extract >1:4000

23. Other dietary or environmental exposures that may place the subject at high risk for prior campylobacter exposure (to be determined on a case-by-case basis by the PI)

24. Employment as a food handler

25. Any other criteria which, in the Principal Investigator's opinion, would compromise the ability of the subject to participate in the study, the safety of the study or the results of the study