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CDI-988 · 1 trial · 1 indication
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
| Arm | Type | Description |
|---|---|---|
| Snow Mountain Virus | OTHER | Challenge with Snow Mountain Virus |
| Stage 2: Drug CDI-988 | EXPERIMENTAL | - |
| Stage 2: Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CDI-988 | DRUG | Antiviral to treat norovirus |
| Placebo | DRUG | Matching placebo |
| Snow Mountain Virus | OTHER | Challenge with Snow Mountain Virus |
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-l...
CDI-988 is an investigational small molecule antiviral being developed by Cocrystal Pharma, Inc. for norovirus. It is an oral protease inhibitor that has completed a Phase 1 human challenge study in healthy adult volunteers in the United States. It has received Fast Track designation from the FDA.
CDI-988 is being developed to treat norovirus infection. Its clinical program has studied the drug in healthy adults challenged with Snow Mountain Virus, a norovirus strain, to evaluate efficacy, safety, and pharmacokinetics. CDI-988 remains investigational and is not approved for any use.
CDI-988 targets a viral protease, an enzyme essential to norovirus replication. By inhibiting this protease, the small molecule is designed to interfere with the virus's ability to copy itself. The protease mechanism is the basis for its development as an oral antiviral against norovirus.
CDI-988 is being developed by Cocrystal Pharma, Inc., a biopharmaceutical company whose common stock trades under the ticker COCP. Cocrystal is advancing CDI-988 as an oral small molecule antiviral candidate for norovirus in its infectious disease pipeline.
CDI-988 is in Phase 1 development. Its single listed clinical trial, a Phase 1 human challenge study in healthy adults, has been completed. CDI-988 is investigational and has not been approved by the FDA for norovirus or any other indication.
CDI-988 has been studied in one clinical trial, NCT07198139, titled a study to evaluate the efficacy, safety and pharmacokinetics of CDI-988 in healthy adults after challenge with Snow Mountain Virus. The Phase 1 trial was randomized, double-blind, placebo-controlled, enrolled 32 participants in the United States, and is completed.