A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus
Recruiting now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Norovirus
In brief
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.
Key facts
- Study ID
- NCT07198139
- Run by
- Cocrystal Pharma, Inc.
- People needed
- 40
- Starts
- 2026-03-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male or non-pregnant female
- Aged 18 to 49 years
- Good state of health
- Known fucosyl transferase 2 (FUT2) secretor status
You may not qualify if…
- 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
Where it is running
- Hope Clinic of the Emory Vaccine Center — Decatur, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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