Study to Evaluate the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in participants with Chronic Hepatitis B - Trial ANZCTR12623000841673

Timeline & Enrollment

Primary Outcome

To evaluate the safety and tolerability of escalating dose levels of CLB-3000 given as 5 monthly Intramuscular injections in noncirrhotic adults with CHB on stable doses of NUCs Assessments will be done via: • Incidence, severity, and causal relationship of adverse events (AEs), including adverse events of special interest (AESI). Adverse events will be assessed by clinical examination, review of participant daily diary data and self-report. Injection site reaction reports will include measurements of redness and swelling and presence of pain or itch. • Changes in clinical laboratory safety parameters including blood test results for hematology and chemistry. • Changes in vital signs measurements. Vital signs will include measurements of resting heart rate, systolic and diastolic blood pressure (BP) assessed by sphygmomanometer, respiratory rate, and body temperature. • Changes in electrocardiogram (ECG) findings

Summary

An Open-Label Phase 1b Study Evaluating the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in Subjects with Chronic Hepatitis B Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 60 years old. The study population allows for the inclusion of subjects with all possible HBV genotypes Study details This is a Phase 1b, open-label, multicenter, multiple-dose study of Intramuscular (IM) administration of CLB-3000 in noncirrhotic subjects with chronic hepatitis B (CHB) on stable doses of NUCs at study. This study is designed to assess the safety, tolerability, immunogenicity, and antiviral activity of repeated administration of multiple dose levels of CLB-3000 in adults with Chronic Hepatitis B taking stable doses of standard of care nucleoside/nucleotide analogues (NUCs) for viral suppression. Eligible participants will receive 5 monthly Intramuscular (IM) injections of CLB-3000 on Days 1, 30, 60, 90, and 120. The end of the study is defined as the last subject last visit at Day 300. The estimated duration of the study is approximately 11 months (28-day Screening period, 150-day Treatment period, and 150-day Safety follow-up period).

ICD-10 Classifications