NCT07198139

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cocrystal Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Norovirus

Interventions

Type	Name	Description
DRUG	CDI-988	Antiviral to treat norovirus
DRUG	Placebo	Matching placebo
OTHER	Snow Mountain Virus	Challenge with Snow Mountain Virus

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2025-09-30
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study