Phase I Study to Assess Safety and Preliminary Effectiveness of AHB-171 Injection in Healthy Adults and Adults with Chronic Hepatitis B

What this Trial Is About

Researchers are evaluating AHB-171 Injection in a Phase I clinical trial to assess its safety, tolerability, immune response, and pharmacokinetics in both healthy adults and adults with chronic hepatitis B CHB. The study also aims to explore the preliminary effectiveness of AHB-171 in CHB participants. This trial includes two parts Part A with healthy participants and Part B with CHB participants receiving background treatment. Participants receive AHB-171 Injection or placebo via subcutaneous injection. CHB participants also continue stable treatment with nucleostide analogue NA orally. Part A focuses on single ascending doses in healthy adults, while Part B involves multiple ascending doses in CHB participants. The study monitors participants for up to 16 weeks in Part A and up to 48 weeks in Part B, assessing various safety and pharmacokinetic parameters. During the study, participants undergo laboratory tests, physical exams, vital sign checks, electrocardiograms, and ultrasound assessments. Researchers track adverse events and measure drug levels in the blood and urine, as well as immune responses against AHB-171. In CHB participants, viral markers and liver function tests are monitored to evaluate treatment effects. Participants are followed closely throughout the study duration, which may last up to 48 weeks depending on the group.

A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants