Phase 1 Study to Evaluate Safety and Pharmacokinetics of Single-Dose YN001 in Healthy Adults Aged 18 to 65

What this Trial Is About

Researchers are conducting a Phase 1, open-label study to evaluate how the drug YN001 behaves in the body, its safety, and immune response after a single dose in healthy adult volunteers. The study aims to refine the pharmacokinetic profile of YN001 to support its further clinical development. About 24 healthy male and female participants aged 18 to 65 will take part in this research. Participants will be divided into two groups, each receiving a single intravenous infusion of YN001 at either 20 mg or 40 mg. The study includes a maximum 27-day screening period, a baseline day before dosing, the treatment day when the drug is administered, and a follow-up period lasting up to 15 days. After assessments on Day 8, participants will have a final phone visit on Day 15. During the study, participants will undergo various health checks including vital signs, electrocardiograms, laboratory tests, and physical exams. Researchers will measure multiple pharmacokinetic parameters of YN001 such as maximum plasma concentration, time to reach maximum concentration, area under the concentration-time curve, half-life, clearance, and volume of distribution. Safety will be monitored by tracking adverse events and immune responses. Participants involvement will last from screening through Day 15 post-dose.

A Pharmacokinetic Study of YN001 in Healthy Participants