Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPY002-091 · 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 SPY002-091 in a dose escalation format |
| SAD Cohorts 1-5, Placebo Arm | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo |
| SAD Cohort 6 Experimental Arm | EXPERIMENTAL | Participants of Chinese descent will receive a single dose of SPY002-091 |
| SAD Cohorts 6 Placebo Arm | PLACEBO_COMPARATOR | Participants of Chinese descent 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...
SPY002-091 is an investigational small molecule being developed by Spyre Therapeutics, Inc. (NASDAQ: SYRE). It is currently in Phase 1 clinical development. A completed Phase 1 study evaluated the drug in healthy volunteers in the United States.
SPY002-091 is being studied for use in healthy volunteers as part of early clinical development. The completed Phase 1 trial assessed the drug's safety and tolerability in this population. Its intended therapeutic use has not been disclosed.
SPY002-091 is developed by Spyre Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker SYRE. The company is conducting clinical research on this investigational small molecule.
SPY002-091 is in Phase 1 clinical development. A Phase 1 study of the drug in healthy volunteers has been completed. The drug is investigational and has not been approved by regulatory authorities.
SPY002-091 has one completed clinical trial, NCT06672718, titled "A Study of SPY002-091 in Healthy Volunteers." This Phase 1, randomized, double-blind, placebo-controlled study enrolled 50 healthy adults aged 18 years and older in the United States.