Status:
NOT_YET_RECRUITING
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus
Lead Sponsor:
Cocrystal Pharma, Inc.
Conditions:
Norovirus
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
PHASE2
Brief Summary
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 pl...
Detailed Description
This is a single center Phase 1b randomized, double-blind, placebo-controlled study. The primary objective will be to evaluate the efficacy of CDI-988 in comparison to placebo in reducing the incidenc...
Eligibility Criteria
Inclusion
- Healthy male or non-pregnant female
- Aged 18 to 49 years
- Good state of health
- Known fucosyl transferase 2 (FUT2) secretor status
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07198139
Start Date
November 1 2025
End Date
October 1 2026
Last Update
October 6 2025
Active Locations (1)
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1
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States, 30030