Study in Healthy Adults Challenged With Enterotoxigenic E. Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an Orally Administered, Human Monoclonal IgA

Exclusion Criteria

• •1\. Positive pregnancy test at Screening or within 24 h prior to VENBETA6890 or placebo dosing 2. Breastfeeding 3. Poor venous access, as defined by inability to obtain venous blood, for screening labs, after 3 venipuncture attempts 4. Abnormal vital signs, defined as:
• •* Systolic BP \>150 mmHg or Diastolic BP \>90 mmHg
• •* Resting heart rate \>100 bpm
• •* Temperature ≥38.0°C 5. Abnormal electrocardiogram (ECG) parameters, defined as:
• •* PR\>220 msec
• •* QRS\>120 msec
• •* QTcF\>450 msec for males or \>460 msec for females 6. IgA deficiency 7. Evidence of current or past infection with testing for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or Hepatitis B triple screening panel (Hepatitis B surface antigen, Hepatitis B surface antibody, Hepatitis B total core antibody) with confirmatory testing as indicated.
• •8\. Having received prior vaccines for or have had prior infection with ETEC, Heat-Labile Toxin (LT), cholera, Campylobacter, or Shigella, within the past 3 years 9. History of diarrhea during travel to a developing country within the past 3 years 10. History of chronic gastrointestinal illness, including severe dyspepsia, lactose intolerance, or another significant gastrointestinal tract disease (e.g., irritable bowel syndrome, inflammatory bowel syndrome, gastric ulcer disease) 11. Regular use (≥ once weekly) of laxatives, anti-diarrheal agents, anti-constipation agents, or antacid therapies 12. History of major gastrointestinal surgery (uncomplicated laparoscopic appendectomy or cholecystectomy \>1-year prior is permitted) 13. Abnormal bowel habits, as defined by \<3 stools per week or \>2 stools per day in the past 6 months 14. Use of systemic antibiotics within the past 2 weeks prior to Day 1 15. Use of topical (skin), otic, or ophthalmic antibiotics is acceptable, if those doses are not expected to result in significant systemic absorption levels 16. Use of oral, parenteral or high-dose inhaled steroids within 30 days. High-dose oral or parenteral steroids is defined as ≥20 mg total daily dose, or equivalent dose of other glucocorticoids; high-dose inhaled steroids is defined as \>800 μg/day of beclomethasone dipropionate or equivalent.
• •17\. Use of any medication which might affect immune function\* within 30 days
• •\*Examples include anti-cancer drugs, immunomodulating monoclonal antibody therapeutics, and rheumatologic therapies 18. Diagnosis of schizophrenia or other major psychiatric disease 19. Alcohol or drug abuse within last 5 years; current smokers or use of nicotine in any form within 6 months prior to screening and until after end of study.
• •20\. Presence of immunosuppression, which could be due to active neoplastic disease or a history of any hematologic malignancy (excluding resolved non-melanoma skin cancers), radiation therapy, or primary or secondary immunodeficiencies 21. History of allergy to quinolone (e.g., ciprofloxacin) or sulfa drugs (e.g., trimethoprim-sulfamethoxazole) 22. Known history of seizure disorder (remote history of a childhood seizure disorder which has completely resolved is acceptable) 23. Has consumed any nutrients or drugs with known strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors or inducers or P-glycoprotein inhibitors or inducers, starting from 14 days prior to Day 1 until the completion of study procedures at the end of study 24. Another investigational medication within 60 days or 5 half-lives, whichever is longer prior to Day 1 25. Participation in an investigational device study within 60 days prior to Day 1 26. Consumption of prescription and over-the-counter medication (including topical medications), traditional Chinese medicine, or herbal medicine, vitamin, mineral, plant, and other dietary supplements within 14 days or 5 half-lives, whichever is longer, prior to Day 1 and throughout the study 27. Consumption of liquids or foods containing grapefruit or cranberry from 7 days prior to Day 1 (Part A) or Check-in (Part B) and throughout the study 28. Consumption of any food containing poppy seeds from 48 h prior to Day 1 (Part A) or Check-in (Part B) and throughout the study 29. Donation of bone marrow or peripheral stem cells within 90 days prior to Day 1 or blood or plasma within 60 days prior to Day 1 30. Participation in strenuous exercise within 72 h prior to Day 1 (Part A) or Check-in (Part B) 31. Consumption of caffeine-containing substances within 72 h prior to Day 1 (Part A) or Check-in (Part B) 32. Occupation involving the handling of ETEC, cholera, or Shigella bacteria 33. Occupation in food handling industry or care of: very young children (\<2 years old), elderly (≥70 years) or immunocompromised 34. Any other criteria which, in the investigator's opinion, would compromise the safety of the study, the ability of a subject to participate, or the results of the study