Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07198139 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus | PHASE1 | RECRUITING | 40 | — | — | Mar 1, 2026 | Dec 1, 2026 | Feb 17, 2026 | 1 | United States |
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...