NCT06137482

A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Healthy Adult Participants

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN13335, a Platelet-Derived Growth Factor-B Antagonist, in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults. The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is present in the blood of study participants at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	REGN13335	Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
DRUG	Matching Placebo	Administered IV or SC, sequential ascending single dose

Timeline

• Start date: 2023-12-06
• Primary completion: 2025-02-11
• Completion: 2025-02-11
• First posted: 2023-11-18
• Last updated: 2025-03-19

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study