Randomized Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Dose REGN22044 by IV or Subcutaneous Injection in Healthy Adults

What This Trial Is About

Researchers are studying a new drug called REGN22044 in healthy adults aged 18 to 65. This early phase 1 trial aims to understand the safety, tolerability, and how the drug behaves in the body at different doses. It also checks whether the body creates antibodies against REGN22044, which could affect how the drug works or cause side effects. Participants will receive a single dose of REGN22044 either through an intravenous IV injection or a subcutaneous under the skin injection. Some participants will receive a placebo instead, and the study is randomized and double-blind, meaning neither participants nor researchers know who gets the drug or placebo. The study follows a sequential design to test increasing doses in different groups. During the study, participants will be monitored for any side effects up to 18 weeks. Blood samples will be taken to measure the drug concentration and to check for antibodies. Safety assessments will continue throughout to understand how the drug is tolerated. The total participation time spans up to about 18 weeks after dosing.

A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adults