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NCT07198139PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus

Cocrystal Pharma, Inc.

Start Date

3/1/2026

Completion Date

12/1/2026

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 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.

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 incidence of clinical symptoms after challenge with norovirus. Secondary objectives will be to evaluate the efficacy of CDI-988 in comparison to placebo in reducing viral shedding and disease severity and to evaluate the safety of CDI-988 in comparison to placebo.

Eligibility Criteria

Age Range: 18 years to 49 years

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

Interventions

DRUG

CDI-988

DRUG

Placebo

OTHER

Snow Mountain Virus

Interested in This Trial?

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Conditions

Norovirus

Locations

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia 30030

United States