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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 drug being developed by Septerna, Inc. It is a Phase 1 clinical candidate studied in healthy adult volunteers. Its therapeutic indications have not been disclosed. It has completed one Phase 1 trial with 120 participants.
SEP-631 targets MRGPRX2, a G protein-coupled receptor (GPCR). MRGPRX2 is a receptor that has been studied in the context of mast cell activation and related pathways. SEP-631 is a small molecule designed to interact with this GPCR target.
SEP-631 is being developed by Septerna, Inc., which trades under the ticker symbol SEPN. Septerna is a clinical-stage biopharmaceutical company focused on GPCR-targeted drug discovery. SEP-631 is one of its pipeline candidates.
SEP-631 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed.
SEP-631 has been evaluated in one completed Phase 1 trial, NCT07069036, titled "A Study to Evaluate Single and Multiple Doses of SEP-631 in Healthy Adult Volunteers." The trial enrolled 120 healthy adult participants in Australia and was randomized, double-blind, and controlled.