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A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus
A Phase 1b, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Norovirus
Who can join
Ages 18 to 49 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Healthy male or non-pregnant female * Aged 18 to 49 years * Good state of health * Known fucosyl transferase 2 (FUT2) secretor status Exclusion Criteria: * 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
About the study
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.
What is being tested
- CDI-988 (drug)
- Placebo (drug)
- Snow Mountain Virus (other)
Sponsor: Cocrystal Pharma, Inc. · Participants: 40 · Started: Mar 1, 2026
Contact the study team
- David Huang, MD, PhD · Phone: 936-577-5770
Official record on ClinicalTrials.gov — NCT07198139
Locations in the U.S.
| Georgia | Hope Clinic of the Emory Vaccine Center, Decatur |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.