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 studied in healthy volunteers. It is being evaluated for safety, tolerability, and pharmacokinetics. The drug is not approved for any condition and is currently in Phase 1 clinical development.
REGN5069 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile.
REGN5069 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.
REGN5069 has one completed Phase 1 clinical trial, identified as NCT03645746, titled "Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers." The trial enrolled 56 participants in Belgium and was a randomized, double-blind, controlled study.
REGN5069 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy volunteers. The drug is still in clinical development and has not been authorized for any medical use.