Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN5069 · 1 trial · 1 indication
As measured by chemistry, hematology and urinalysis
As measured by heart rate, blood pressure, body temperature and respiratory rate
As measured by heart rate, PR, complex of Q, R, and S waves \[QRS\], QT-intervals, and QTc
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1 will receive a single IV dose of REGN5069 or matching placebo |
| Cohort 2 | EXPERIMENTAL | Cohort 2 will receive a single sequential ascending IV dose of REGN5069 or matching placebo |
| Cohort 3 | EXPERIMENTAL | Cohort 3 will receive a single sequential ascending IV dose of REGN5069 or matching placebo |
| Cohort 4 | EXPERIMENTAL | Cohort 4 will receive a single sequential ascending IV dose of REGN5069 or matching placebo |
| Cohort 5 | EXPERIMENTAL | Cohort 5 will receive a single SC dose of REGN5069 or matching placebo |
| Cohort 6 | EXPERIMENTAL | Cohort 6 will receive a single sequential ascending SC dose of REGN5069 or matching placebo |
| Cohort 7 | EXPERIMENTAL | Cohort 7 will receive a single sequential ascending IV dose of REGN5069 or matching placebo |
| Name | Type | Description |
|---|---|---|
| REGN5069 | DRUG | REGN5069 will be administered by IV infusion or SC injection |
| Placebo | DRUG | Placebo-matching REGN5069 |
Key Inclusion Criteria: * Participant is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG performed at screening and/or prior to study drug dosing * Participant is in good health based on laboratory safety testing obtai...
REGN5069 is an investigational small molecule being developed by Regeneron Pharmaceuticals, Inc. It has completed a Phase 1 clinical trial in healthy volunteers. No approved indication has been announced for REGN5069, and it remains in clinical development.
REGN5069 targets GFRa3, also known as GDNF family receptor alpha 3. GFRa3 is a cell surface receptor involved in neurotrophic signaling. The drug is a small molecule designed to interact with this target, though its precise mechanism of action has not been publicly detailed.
REGN5069 is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol REGN. Regeneron is a biotechnology company focused on developing medicines for serious medical conditions.
REGN5069 is in Phase 1 clinical development. It has completed one Phase 1 trial in healthy volunteers. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
REGN5069 has been evaluated in one completed Phase 1 trial, NCT03645746, titled Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers. The trial enrolled 56 participants in Belgium and was randomized, double-blind, and controlled.