CDI-988 for Norovirus

DH
Overseen ByDavid Huang, MD, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Cocrystal Pharma, Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CDI-988 to determine if it can reduce symptoms when exposed to norovirus, which causes stomach issues like vomiting and diarrhea. Participants will receive either CDI-988 or a placebo and then be exposed to the virus to compare symptom severity between groups. The study will measure virus levels in stool samples and examine how the body processes the treatment. The trial seeks healthy individuals aged 18 to 49 who know their fucosyl transferase 2 (FUT2) secretor status, which influences the body's response to certain infections. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or high-dose steroids, you may not be eligible to participate.

Is there any evidence suggesting that CDI-988 is likely to be safe for humans?

Research has shown that CDI-988 is generally safe for people. In a previous study, researchers administered CDI-988 to healthy adults, and the results indicated it was safe to use. Most participants did not experience serious side effects, and no major health issues were reported. This is encouraging for those considering joining the trial, as it suggests the treatment has been safe in past human tests.12345

Why do researchers think this study treatment might be promising?

CDI-988 is unique because it targets norovirus, which currently lacks a specific antiviral treatment. Most existing options, like oral rehydration solutions and antiemetic drugs, only manage symptoms rather than tackling the virus itself. Researchers are excited about CDI-988 because it introduces a novel approach to treating norovirus by potentially inhibiting the virus directly. This could mean faster relief from symptoms and reduced transmission, making it a groundbreaking advancement in managing this common and highly contagious infection.

What evidence suggests that CDI-988 might be an effective treatment for norovirus?

Research has shown that CDI-988, which participants in this trial may receive, effectively targets important norovirus types, specifically GII.4 and GII.17. In studies, CDI-988 targets key proteins that the virus needs to grow and spread. Early results from human trials suggest that CDI-988 can lessen norovirus symptoms, which often include uncomfortable issues like vomiting and diarrhea. While more information is needed, the drug's ability to block these vital proteins makes it a promising option for treating norovirus infections.12345

Who Is on the Research Team?

NR

Nadine Rouphael, MD

Principal Investigator

Hope Clinic of the Emory Vaccine Center

Are You a Good Fit for This Trial?

This trial is for healthy adults who can safely be exposed to the Snowy Mountain Virus, which causes symptoms similar to Norovirus. Participants must not have any known immunity or previous exposure to this virus and should be in good health without chronic medication use that could affect the study.

Inclusion Criteria

Good state of health
I am between 18 and 49 years old.
I am a healthy male or a non-pregnant female.
See 1 more

Exclusion Criteria

History of participation in any norovirus challenge or vaccine clinical trial
Positive Day 0 stool tests for enteric pathogens
My weight is under 45 kg, or my BMI is below 18 or above 32.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CDI-988 or placebo orally before receiving a norovirus challenge virus and continue for 5 days

5 days
Daily visits (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measuring the amount of virus in stool samples and side effects

16 days

What Are the Treatments Tested in This Trial?

Interventions

  • CDI-988
Trial Overview The study tests CDI-988's ability to prevent or reduce symptoms of a norovirus-like illness when taken orally before and after being exposed to the Snowy Mountain Virus. It compares results from people taking CDI-988 with those on a placebo over five days.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Stage 2: Drug CDI-988Experimental Treatment2 Interventions
Group II: Snow Mountain VirusExperimental Treatment1 Intervention
Group III: Stage 2: PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cocrystal Pharma, Inc.

Lead Sponsor

Trials
5
Recruited
350+

Citations

NCT07198139 | A Study to Evaluate the Efficacy, Safety ...The study will evaluate how well CDI-988 compared to placebo can reduce the incidence of clinical symptoms after a challenge with norovirus. The ...
Cocrystal Pharma Receives FDA IND Clearance for ...CDI-988 has shown effectiveness against major norovirus proteases including the prevalent GII.4 and GII.17. Data from the Phase 1 study showed ...
Cocrystal Pharma's CDI-988: A Promising Antiviral in ...The study aims to assess the effectiveness and safety of the antiviral drug CDI-988 in reducing norovirus symptoms, a significant cause of ...
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics ...The study will evaluate how well CDI-988 compared to placebo can reduce the incidence of clinical symptoms after a challenge with norovirus. The ...
Sam Lee, PhD Oral Direct-Acting Antiviral CDI-988 for ...▫ Cocrystal CDI-988 human challenge study using Snow Mountain Virus (GII.2) planned ... ▫ Norovirus challenge study as a surrogate for clinical ...
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