CDI-988 to prevent norovirus symptoms after controlled exposure
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
This will test whether taking CDI-988 before a controlled norovirus exposure can reduce symptoms in healthy adults aged 18–49.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | Cocrystal Pharma, Inc. Industry-sponsored |
| Locations | 1 site (Decatur, Georgia) |
| Trial ID | NCT07198139 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized, double-blind, placebo-controlled Phase 1b study in healthy adults. Participants with known FUT2 secretor status will receive oral CDI-988 or placebo before and for five days after being given a controlled dose of Snow Mountain norovirus. The study will compare the incidence of clinical symptoms, measure viral levels in stool over time, and collect safety and pharmacokinetic (blood level) data. Results will inform whether CDI-988 reduces disease and viral shedding compared with placebo.
Who should consider this trial
Good fit: Healthy men or non-pregnant women aged 18–49 with known FUT2 secretor status who are willing to undergo a controlled norovirus challenge and meet the study's health and BMI requirements.
Not a fit: People with chronic gastrointestinal disorders, recent or planned vaccinations, immunosuppression, prior participation in norovirus challenge/vaccine trials, or those outside the specified age/BMI ranges are unlikely to be eligible or benefit from this study.
Why it matters
Potential benefit: If successful, CDI-988 could reduce the frequency and severity of norovirus symptoms and shorten the duration of viral shedding in exposed adults.
How similar studies have performed: Human norovirus challenge models have been used to test vaccines and antivirals with mixed early-stage results, and targeted antiviral treatment for norovirus remains largely experimental.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Decatur, Georgia
- Hope Clinic of the Emory Vaccine Center — Decatur, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Nadine Rouphael, MD — Hope Clinic of the Emory Vaccine Center
- Study coordinator: David Huang, MD, PhD
- Email: dhuang@cocrystalpharma.com
- Phone: 936-577-5770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.