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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-10-01

Brief Summary

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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.

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Detailed Description

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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

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Norovirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Snow Mountain Virus

Challenge with Snow Mountain Virus

Group Type OTHER

Snow Mountain Virus

Intervention Type OTHER

Challenge with Snow Mountain Virus

Stage 2: Drug CDI-988

Group Type EXPERIMENTAL

CDI-988

Intervention Type DRUG

Antiviral to treat norovirus

Snow Mountain Virus

Intervention Type OTHER

Challenge with Snow Mountain Virus

Stage 2: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Snow Mountain Virus

Intervention Type OTHER

Challenge with Snow Mountain Virus

Interventions

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CDI-988

Antiviral to treat norovirus

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Snow Mountain Virus

Challenge with Snow Mountain Virus

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes