Phase I Study of SYH2061 for Safety and Effects in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of SYH2061 in healthy adult volunteers. This study is a randomized, double-blind, placebo-controlled, single-ascending dose trial designed to gather important early information about SYH2061. The trial is sponsored by CSPC Zhongnuo Pharmaceutical Shijiazhuang Co., Ltd. and focuses on healthy subjects aged 18 to 55 years. Participants are randomly assigned to receive a single subcutaneous injection of either SYH2061 or a placebo on Day 1. The study follows a single-dose design, assessing the effects of the drug compared to placebo. The double-blind setup means neither participants nor researchers know who receives the drug or placebo during the trial. Throughout the study, participants will undergo physical exams, vital signs monitoring, ECGs, chest X-rays, abdominal ultrasounds, and laboratory tests. Researchers will track adverse events up to Day 337 and measure SYH2061 levels in the blood for up to 72 hours after dosing. They will also monitor changes in complement system components and immune responses over time. The study lasts several months to ensure safety and gather detailed pharmacological data.

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2061