Recruiting
Phase 1
Phase 2

CDI-988

Sponsor:

Cocrystal Pharma, Inc.

Code:

NCT07198139

Conditions

Norovirus

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

CDI-988

Placebo

Snow Mountain Virus

Study Details

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

Study ID

NCT07198139

Start date

Mar 1, 2026

Status verified date

Feb, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Snow Mountain Virus

Challenge with Snow Mountain Virus

experimental: Stage 2: Drug CDI-988

placebo comparator: Stage 2: Placebo

Interventions

CDI-988

Antiviral to treat norovirus

Placebo

Matching placebo

Snow Mountain Virus

Challenge with Snow Mountain Virus

Primary outcome measure

  • Incidence of norovirus-confirmed disease [ Time Frame: Day 0 to Day 21 ]

Central Contacts and Locations

Central contacts

David Huang, MD, PhD

936-577-5770dhuang@cocrystalpharma.com

Locations

Hope Clinic of the Emory Vaccine Center

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Veronica Smith

404-712-1370

More Information

Sponsor

Cocrystal Pharma, Inc.

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • tolerability
  • viral challenge model
  • antiviral

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cocrystal Pharma, Inc. on 2026-02-17.