Clinical Study to Assess the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection Model

Inclusion criteria

• ✓. Male or female between 18 and 50 years of age, inclusive at time of screening visit.
• ✓. General good health, without significant medical illness, abnormal vital signs or physical examination findings, or clinical laboratory abnormalities, as determined by the principal investigator (PI) in consultation with the Medical Monitor and Sponsor.
• ✓. Demonstrate comprehension of the protocol procedures, requirements, and CHIM this will be evaluated by completing a multiple choice comprehension assessment (passing grade \> 70%) during screening and in the consenting process.
• ✓. Willing to participate, as evidenced by signing the informed consent document.
• ✓. Available for all planned follow-up visits.
• ✓. Negative serum pregnancy test at screening and negative serum and/or urine pregnancy test on the day of admittance to the inpatient unit for all female participants. All females must agree to use an efficacious hormonal or barrier method of birth control during the study. Efficacious methods of birth control include hormonal birth control methods (oral contraceptive pills, patches, vaginal rings, long-acting reversible contraception, surgical sterilization, condoms with spermicide, or abstinence from intercourse with a male partner. Female participants unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).
• ✓. A negative Covid-19 PCR test is required on the day of admission to the unit to comply with Pharmaron's Covid-19 policy (subjects reporting to admission for Cohort 1 who test positive for COVID-19 may rescreen for Cohort 2)
• ✓. Acceptable hematology and blood chemistry levels as assessed by the PI. i.e., Serum creatinine \<1.3 mg/dL. AST, GGT, amylase, lipase, alkaline phosphatase not to exceed 1.5x upper limit of normal (ULN)

Exclusion criteria