A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus

Exclusion Criteria10

• History of participation in any norovirus challenge or vaccine clinical trial
• Receipt or planned receipt of any non-live vaccines within 7 days or live vaccines within 30 days before screening or prior to Day 28
• History of suspected norovirus gastroenteritis or chronic/recurrent gastrointestinal symptoms (e.g., diarrhea or vomiting) within 2 years prior to screening
• History of diagnosed gastrointestinal malabsorption disorders, major gastrointestinal surgery, or diagnosed chronic GI conditions
• Presence of moderate or severe illness, fever (≥38°C), or diarrhea/vomiting within 7 days prior to challenge
• Any acute illness on Day 1 (dosing day)
• Positive Day 0 stool tests for enteric pathogens
• Body weight <45 kg or BMI <18 or >32 kg/m² on Day 0
• Use of immunosuppressive therapy within 6 months prior to Day 0 or having any primary or secondary immunocompromising condition
• Use of high-dose systemic corticosteroids (≥20 mg/day prednisolone for ≥2 weeks) or high-dose inhaled steroids for >7 days within 6 months