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CDI-988 · 2 trials · 2 indications
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
number of participants with treatment-emergent adverse events
number of participants with clinically significant laboratory abnormalities
number of participants with clinically significant changes from baseline in vital signs
number of participants with clinically significant changes from baseline in ECGs
| Arm | Type | Description |
|---|---|---|
| Snow Mountain Virus | OTHER | Challenge with Snow Mountain Virus |
| Stage 2: Drug CDI-988 | EXPERIMENTAL | - |
| Stage 2: Placebo | PLACEBO_COMPARATOR | - |
| SAD Cohort 1A | EXPERIMENTAL | first single-dose level |
| SAD Cohort 1B | EXPERIMENTAL | second single-dose level |
| SAD Cohort 1C | EXPERIMENTAL | third single-dose level; food-effect cohort |
| SAD Cohort 1D | EXPERIMENTAL | fourth single-dose level |
| MAD Cohort 2A | EXPERIMENTAL | first multiple-dose level |
| MAD Cohort 2B | EXPERIMENTAL | second multiple-dose level |
| MAD Cohort 2C | EXPERIMENTAL | third multiple-dose level |
| SAD Cohort 1E | EXPERIMENTAL | fifth dose level; food effect cohort |
| SAD Cohort 1F | EXPERIMENTAL | sixth dose level |
| MAD Cohort 2D | EXPERIMENTAL | 4th multiple dose level |
| MAD Cohort 2E | EXPERIMENTAL | 5th multiple dose level |
| MAD Cohort 2F | EXPERIMENTAL | 6th multiple dose level |
| 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 being developed by Cocrystal Pharma, Inc. (NASDAQ: COCP) for the prevention or treatment of norovirus infection. It is currently being evaluated in healthy volunteers in a Phase 1 human challenge study to assess its efficacy, safety, and pharmacokinetics after exposure to the Snow Mountain virus.
CDI-988 targets the viral protease enzyme, which is essential for norovirus replication. By inhibiting this enzyme, the drug aims to block the virus's ability to multiply in the body. This mechanism is being studied in clinical trials for its potential to treat or prevent norovirus infection.
CDI-988 is being developed by Cocrystal Pharma, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol COCP. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for norovirus infection.
CDI-988 is in Phase 1 clinical development. It has completed a Phase 1 safety study in healthy participants and is currently recruiting for another Phase 1 trial that evaluates its efficacy in healthy adults challenged with Snow Mountain virus. It is not yet approved by the FDA and remains investigational.
CDI-988 has been studied in two Phase 1 trials. NCT05977140 was a completed safety study in 94 healthy participants in Australia. NCT07198139 is an ongoing, recruiting trial in the United States that will enroll 40 healthy adults to evaluate the drug's efficacy, safety, and pharmacokinetics after challenge with Snow Mountain virus.
CDI-988 is a distinct investigational drug candidate developed by Cocrystal Pharma. It is not known to be the same as any other marketed or approved medication. Its unique protease inhibitor mechanism is being studied specifically for norovirus, and no alternative names have been reported.