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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06672718 | A Study of SPY002-091 in Healthy Volunteers | PHASE1 | RECRUITING | 56 | — | — | Nov 26, 2024 | Jun 22, 2026 | Aug 17, 2025 | 1 | United States |
Incidence, severity, and causal relationship of TEAEs
| Arm | Type | Description |
|---|---|---|
| SAD Cohorts, Experimental Arm | EXPERIMENTAL | Participants will receive a single dose of SPY002-091 in a dose escalation format |
| SAD Cohorts, Placebo Arm | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo |
| Name | Type | Description |
|---|---|---|
| SPY002-091 | DRUG | Experimental |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Healthy men and women * Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits Exclusion Criteria: * Participation in more...