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Recruiting NCT07198139

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

Phase I / Phase II Interventional Norovirus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CDI-988, Placebo, Snow Mountain Virus.
Who it may be relevant to
Registry conditions: Norovirus. Basic parameters: 18 years — 49 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug CDI-988
    Antiviral to treat norovirus
  • Drug Placebo
    Matching placebo
  • Other Snow Mountain Virus
    Challenge with Snow Mountain Virus

Primary outcome measures

  • Incidence of norovirus-confirmed disease [Time frame: Day 0 to Day 21]
Secondary outcome measures (9)
  • Modified Vesikari Score (MVS) symptom scores during the inpatient period in infected patients [Time frame: Day 1 to Day 6]
  • Time to symptom improvement [Time frame: Day 1 to Day 6]
  • Time to first SMV-negative stool [Time frame: Day 1 to Day 6]
  • Area Under the Curve of SMV load [Time frame: Day 1 to Day 21]
  • Incidence of treatment emergent adverse events [Time frame: Day 0 to Day 21]
  • Incidence of serious adverse events [Time frame: From signing informed consent to Day 21]
  • Maximum plasma concentration of CDI-988 [Time frame: Day 0 and Day 4 pre-dose and at 2, 3, 4, 6, 8, and 12 hours]
  • Time of maximum plasma concentration of CDI-988 [Time frame: Day 0 and Day 4 pre-dose and at 2, 3, 4, 6, 8, and 12 hours]
  • Area under the plasma concentration time curve [Time frame: Day 0 and Day 4 pre-dose and at 2, 3, 4, 6, 8, and 12 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Hope Clinic of the Emory Vaccine Center — Decatur

Identifiers

NCT: NCT07198139 · CDI-988-P1b-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗