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REGN9035 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Single ascending dose (SAD) of REGN9035 or matching placebo given by intravenous (IV) administration. |
| Part B | EXPERIMENTAL | Selected doses of REGN5381 or matching placebo given by IV administration followed by selected doses of REGN9035 and/or matching placebo via IV infusion |
| Name | Type | Description |
|---|---|---|
| REGN9035 | DRUG | Part A: Single dose administered by IV infusion on day 1. Part B: Selected doses administered by IV infusion on day 2 or 22. |
| REGN5381 | DRUG | Part B: Selected doses administered by IV infusion on day 1. |
| Placebo | OTHER | Part A: Single dose administered by IV infusion on day1. Part B: Single dose administered by IV infusion on day 1, day 2 and/or day 22. |
Key Inclusion Criteria: 1. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at the screening visit. 2. Normal or mildly elevated blood pressure as defined in the protocol. Key Exclusion Criteria: 1. History of unexplained syncope or autonomic dysfunction. 2. History of clinically signifi...
REGN9035 is an investigational small molecule developed by Regeneron Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers and mildly hypertensive participants. The specific indications for which REGN9035 is being developed have not been disclosed.
REGN9035 targets NPR1, a protein also known as the natriuretic peptide receptor 1. NPR1 is a receptor involved in cardiovascular and fluid regulation. By binding to NPR1, REGN9035 is designed to modulate signaling through this receptor pathway.
REGN9035 is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol REGN. Regeneron is the sponsor of the clinical program evaluating this small molecule.
REGN9035 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed.
REGN9035 has been evaluated in one completed Phase 1 trial, NCT05291546. The study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of REGN9035 in healthy adult volunteers and mildly hypertensive participants. It enrolled 93 participants across Belgium and Germany and was randomized, double-blind, and controlled.
The REGN9035 Phase 1 trial, NCT05291546, was a randomized, double-blind, controlled study. It enrolled 93 participants aged 18 years and older, including healthy volunteers and mildly hypertensive participants, and was conducted in Belgium and Germany. The trial evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics, and it has been completed.