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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06448247 | A Study of SPY001-001 in Healthy Volunteers | PHASE1 | COMPLETED | 96 | — | — | Jun 6, 2024 | Mar 10, 2026 | Mar 20, 2026 | 2 | United States, Canada |
Incidence, severity, and causal relationship of TEAEs
| Arm | Type | Description |
|---|---|---|
| SAD Cohorts 1-5 Experimental Arm | EXPERIMENTAL | Participants will receive a single dose of SPY001-001 in a dose escalation format |
| SAD Cohorts 1-5 Placebo Arm | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo |
| MAD Cohorts 1-2 Experimental Arm | EXPERIMENTAL | Participants will receive two doses of SPY001-001 in a dose escalation format |
| MAD Cohorts 1-2 Placebo Arm | PLACEBO_COMPARATOR | Participants will receive two doses of placebo |
| SAD Cohorts 6-7 Experimental Arm | EXPERIMENTAL | Participants of Japanese descent will receive a single dose of SPY001-001 |
| SAD Cohorts 6-7 Placebo Arm | PLACEBO_COMPARATOR | Participants of Japanese descent will receive a single dose of placebo |
| SAD Cohorts 8-9 Experimental Arm | EXPERIMENTAL | Participants of Chinese descent will receive a single dose of SPY001-001 |
| SAD Cohorts 8-9 Placebo Arm | PLACEBO_COMPARATOR | Participants of Chinese descent will receive a single dose of placebo |
| Name | Type | Description |
|---|---|---|
| SPY001-001 | 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...