Actively Recruiting
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus
Led by Cocrystal Pharma, Inc. · Updated on 2026-02-17
40
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Participants in this study will be given either CDI-988 or placebo orally before receiving a norovirus challenge virus and continuing for 5 days. Participants will not know whether they are getting placebo or CDI-988. The study will evaluate how well CDI-988 compared to placebo can reduce the incidence of clinical symptoms after a challenge with norovirus. The amount of virus in stool samples will be measured over time. Side effects and pharmacokinetics (the amount of CDI-988 in blood) will also be measured.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or non-pregnant female
- Aged 18 to 49 years
- Good state of health
- Known fucosyl transferase 2 (FUT2) secretor status
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States, 30030
Actively Recruiting
Research Team
D
David Huang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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