Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SEP-631 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose | EXPERIMENTAL | - |
| Multiple Ascending Dose | EXPERIMENTAL | - |
| Food Effect | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SEP-631 | DRUG | Oral, tablet |
| Placebo | OTHER | Oral, tablet |
Inclusion Criteria: 1. Subjects who are able and willing to provide informed consent 2. Aged 18 to 60 years at the time of consent 3. Have a BMI within the range 18.5 to 32.0 kg/m2 4. In general good health Exclusion Criteria: 1. Any condition, which in the investigator's opinion might jeopardize...
SEP-631 is an investigational small molecule being developed by Septerna, Inc. (NASDAQ: SEPN). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is not approved and remains under investigation.
SEP-631 is being studied for use in healthy volunteers. It is an investigational small molecule in Phase 1 clinical development. The ongoing research aims to evaluate its safety and tolerability in this population.
SEP-631 is being developed by Septerna, Inc., a biopharmaceutical company traded on NASDAQ under the ticker SEPN. The company is conducting clinical trials to evaluate the drug in healthy volunteers.
SEP-631 is in Phase 1 clinical development. It is an investigational drug being studied in healthy volunteers. The drug is not FDA approved and remains in clinical trials.
SEP-631 has one completed Phase 1 trial, NCT07069036, which evaluated single and multiple doses in healthy adult volunteers. The study enrolled 120 participants in Australia and was randomized, double-blind, and controlled.