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

NCT07198139 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CDI-988-P1b-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Norovirus

Keywords

tolerability; viral challenge model; antiviral

Outcome Measures

Primary Outcomes (1)

• Incidence of norovirus-confirmed disease

  Disease is defined as diarrhea and/or vomiting (during the inpatient period), with laboratory-confirmed infection (with SMV specific primers on stool/emesis) or seroconversion

  Day 0 to Day 21

Secondary Outcomes (9)

• Modified Vesikari Score (MVS) symptom scores during the inpatient period in infected patients

  Day 1 to Day 6

• Time to symptom improvement

  Day 1 to Day 6

• Time to first SMV-negative stool

  Day 1 to Day 6

• Area Under the Curve of SMV load

  Day 1 to Day 21

• Incidence of treatment emergent adverse events

  Day 0 to Day 21

Study Arms (3)

Snow Mountain Virus

OTHER

Challenge with Snow Mountain Virus

Other: Snow Mountain Virus

Stage 2: Drug CDI-988

EXPERIMENTAL

Drug: CDI-988; Other: Snow Mountain Virus

Stage 2: Placebo

PLACEBO COMPARATOR

Drug: Placebo; Other: Snow Mountain Virus

Interventions

CDI-988 DRUG

Antiviral to treat norovirus

Stage 2: Drug CDI-988

Placebo DRUG

Matching placebo

Stage 2: Placebo

Snow Mountain Virus OTHER

Challenge with Snow Mountain Virus

Snow Mountain Virus; Stage 2: Drug CDI-988; Stage 2: Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or non-pregnant female
• Aged 18 to 49 years
• Good state of health
• Known fucosyl transferase 2 (FUT2) secretor status

You may not qualify if:

• 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

Sponsors & Collaborators

• Cocrystal Pharma, Inc.: lead

Study Sites (1)

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

RECRUITING

Study Officials

• Nadine Rouphael, MD

  Hope Clinic of the Emory Vaccine Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Huang, MD, PhD

CONTACT

936-577-5770; dhuang@cocrystalpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 30, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)