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REGN9533 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| REGN9533 | EXPERIMENTAL | Randomized as described in the protocol Escalating Cohorts including Optional Cohorts |
| Placebo | EXPERIMENTAL | Randomized as described in the protocol |
| Name | Type | Description |
|---|---|---|
| REGN9533 | DRUG | Administered per the protocol |
| Matching Placebo | DRUG | Administered per the protocol. |
Key Inclusion Criteria: 1. Has a body mass index between 18 and 32 kg/m2, inclusive 2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of i...
REGN9533 is an investigational small molecule being developed by Regeneron Pharmaceuticals, Inc. It is in Phase 1 clinical development, with one completed Phase 1 trial conducted in healthy adult volunteers. Regeneron is exploring REGN9533 in the context of end-stage kidney disease (ESKD).
REGN9533 is being investigated for end-stage kidney disease (ESKD), a condition in which the kidneys no longer function adequately. The program remains in Phase 1 development, and the completed trial enrolled healthy adult volunteers rather than patients with ESKD, so no efficacy in ESKD has been established.
REGN9533 is developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is the sponsor of the REGN9533 clinical program, including the completed Phase 1 study conducted in Belgium.
REGN9533 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The program is investigational and has not been approved by the FDA for any indication.
REGN9533 has been studied in one Phase 1 trial, NCT06665828, titled a Phase 1 Safety and Tolerability Study of REGN9533 in Healthy Adults. The trial was completed, enrolled 72 participants, was randomized, double-blind, and controlled, and was conducted in Belgium.
The Phase 1 trial of REGN9533, NCT06665828, enrolled 72 healthy adult volunteers aged 18 years and older of all sexes. It was a randomized, double-blind, controlled study conducted in Belgium, and it has been completed.