Phase 1 Study to Assess Safety and Effects of Single Increasing Doses of DF5112 Given Intravenously or Under the Skin in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of DF5112 in healthy adult participants. This Phase 1, double-blind, randomized, placebo-controlled study involves single ascending doses of DF5112 given to healthy volunteers aged 18 to 55 years. The study aims to understand how the drug behaves in the body and any effects it may cause. Participants will be assigned to one of six groups, each with 8 healthy adults randomized to receive either a single dose of DF5112 or a placebo. The drug or placebo will be administered either intravenously or subcutaneously. Additional intermediate dose groups may be added. After receiving the dose, participants will remain in the clinical research unit for about one week for observation. Following this confinement period, participants will return for follow-up visits through Day 29 to monitor safety and collect data. Researchers will assess adverse events, measure drug levels in the body, and check for immune responses against the drug. The total study duration for each participant is approximately 29 days, including dosing, observation, and follow-up.

A Study to Evaluate the Safety of Increasing Doses of DF5112 in Healthy Adults