Randomized, Double-blind, Placebo-controlled Phase I Trial Evaluating Safety and Antiviral Effects of HECN30227 Injection in Healthy Volunteers and Chronic Hepatitis B Patients

What This Trial Is About

Researchers are studying the safety, effectiveness, how the body processes, and immune response of different doses of HECN30227 Injection in both healthy volunteers and people with chronic hepatitis B. This phase I randomized, double-blind, placebo-controlled trial aims to evaluate single and multiple doses of the drug to better understand its impact on the condition. Participants will receive either single or multiple subcutaneous injections of HECN30227 or a placebo 0.9% Sodium Chloride Injection in separate groups. The study includes dose escalation with varying amounts of the drug administered. Both healthy participants and those with chronic hepatitis B will be enrolled and followed during the dosing periods. During the trial, participants will be monitored for adverse events, drug levels in the blood, and antiviral activity. Assessments include blood tests for viral markers and liver function, along with physical exams and imaging at baseline. The study tracks safety and drug effects over periods up to 169 days, with particular attention to side effects and changes in hepatitis B surface antigen levels.

A Phase I Clinical Trial to Evaluate HECN30227 Injection in Healthy Subjects and Subjects With Chronic Hepatitis B