NCT07198139

CompletedPhase 1/2

A Study to Evaluate the Efficacy, Safety and Pharmacokinetic...

Cocrystal Pharma, Inc.Source

Cocrystal Pharma, Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CDI-988-P1b-001

Study Type

interventional

Actual enrollment (reported)

32

Locations

1 country

Sites

1

Timeline

Study Start

February 23, 2026

Actual (reported)

Primary Completion

September 14, 2026

Actual (reported)

Study Completion

September 14, 2026

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 32 participants
Study completion date: September 14, 2026
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 15, 2025
Actual (reported)
First Posted
September 30, 2025
Actual (reported)
Study Start
February 23, 2026
Actual (reported)
Primary Completion
September 14, 2026
Actual (reported)
Study Completion
September 14, 2026
Actual (reported)

Last Updated: October 22, 2026
Status Verified: October 2026
Last Update Submitted: October 20, 2026

Conditions

Norovirus

Keywords

tolerabilityviral challenge modelantiviral

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
+4 more secondary outcomes

Study Arms (3)

Snow Mountain Virus

OTHER

Challenge with Snow Mountain Virus

Other: Snow Mountain Virus

Stage 2: Drug CDI-988

EXPERIMENTAL

Drug: CDI-988Other: Snow Mountain Virus

Stage 2: Placebo

PLACEBO COMPARATOR

Drug: PlaceboOther: Snow Mountain Virus

Interventions

CDI-988Drug

Antiviral to treat norovirus

Stage 2: Drug CDI-988

PlaceboDrug

Matching placebo

Stage 2: Placebo

Eligibility Criteria

Age18 Years - 49 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy male or non-pregnant female
Aged 18 to 49 years

Sponsors & Collaborators

Cocrystal Pharma, Inc.
Industrylead

Study Sites (1)

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

Study Officials

Nadine Rouphael, MD
Hope Clinic of the Emory Vaccine Center
PRINCIPAL INVESTIGATOR

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
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

February 23, 2026

Actual (reported)

NCT05977140

CDI-988 Safety Study in Healthy Participants

Phase 1Completed

NCT02475278

Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine

Phase 2Completed

NCT03039790

Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults

Phase 2Completed

Snow Mountain VirusOther

Challenge with Snow Mountain Virus

Snow Mountain VirusStage 2: Drug CDI-988Stage 2: Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Contact the study team to confirm eligibility.

Primary Completion

September 14, 2026

Actual (reported)

Study Completion

September 14, 2026

Actual (reported)

Last Updated

October 22, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07198139
Data provider: ClinicalTrials.gov
Source updated: 2026-10-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:50 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (3)

Snow Mountain Virus

Stage 2: Drug CDI-988

Stage 2: Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations