Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPY001-001 · 1 trial · 1 indication
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...
SPY001-001 is an investigational small molecule being developed by Spyre Therapeutics, Inc. It is currently in Phase 1 clinical development. The drug has been studied in a completed trial involving healthy volunteers, with a total enrollment of 96 participants. It is not yet approved and remains under clinical investigation.
SPY001-001 is being studied for use in healthy volunteers as part of early clinical development. The completed Phase 1 trial, NCT06448247, was designed to evaluate the drug in healthy participants. Its intended therapeutic use has not been established, as it is still in the investigational stage.
SPY001-001 is being developed by Spyre Therapeutics, Inc., a biopharmaceutical company. The company's ticker symbol is SYRE. Spyre Therapeutics is responsible for the clinical development of this investigational small molecule drug.
SPY001-001 is in Phase 1 clinical development. A Phase 1 trial, NCT06448247, has been completed. This trial was a randomized, double-blind, placebo-controlled study in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
SPY001-001 has one completed clinical trial, NCT06448247, titled 'A Study of SPY001-001 in Healthy Volunteers.' This Phase 1 study enrolled 96 healthy participants in the United States and Canada. The trial was randomized, double-blind, and placebo-controlled, and included adults aged 18 years and older.
SPY001-001 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is being developed by Spyre Therapeutics, Inc. under this designation, and no other names have been associated with it in clinical trial records.