Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPY003-207 · 1 trial · 1 indication
Incidence, severity, and causal relationship of TEAEs
| Arm | Type | Description |
|---|---|---|
| SAD Cohorts 1-6 Experimental Arm | EXPERIMENTAL | Participants will receive a single dose of SPY003-207 in a dose escalation format |
| SAD Cohorts 1-6 Placebo Arm | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo |
| SAD Cohort 7, Experimental Arm | EXPERIMENTAL | Participants of Chinese descent will receive a single dose of SPY003-207-101 |
| SAD Cohort 7, Placebo Arm | PLACEBO_COMPARATOR | Participants of Chinese descent will receive a single dose of placebo |
| MAD Cohorts 1 Experimental Arm | EXPERIMENTAL | Participants will receive two doses of SPY003-207-101 in a dose escalation format |
| MAD Cohorts 1 Placebo Arm | PLACEBO_COMPARATOR | Participants will receive two doses of placebo |
| Name | Type | Description |
|---|---|---|
| SPY003-207 | 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...
SPY003-207 is an investigational small molecule being studied in healthy volunteers. It is currently in a Phase 1 clinical trial to evaluate its safety and tolerability. The drug is not approved for any condition and is in early-stage clinical development.
SPY003-207 is being developed by Spyre Therapeutics, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol SYRE. Spyre Therapeutics is conducting the Phase 1 clinical trial of this investigational small molecule.
SPY003-207 is in Phase 1 clinical development. It is an investigational drug being studied in a Phase 1 trial in healthy volunteers. The drug has not been approved by regulatory authorities and is still in the early stages of clinical testing.
SPY003-207 is being studied in a Phase 1 clinical trial with the identifier NCT06873724. This trial is titled 'A Study of SPY003-207 in Healthy Volunteers' and is active but not recruiting. The study is enrolling 59 participants in the United States and Canada.
SPY003-207 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied in a clinical trial in healthy volunteers to assess its safety and tolerability, but it has not received regulatory approval for any use.