Study to Evaluate the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in participants with Chronic Hepatitis B
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
ClearB Therapeutics, Inc.
12 participants
Sep 11, 2023
Interventional
Conditions
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).
Eligibility
Inclusion Criteria6
- Able to give written informed consent.
- Age 18 to 60 years, inclusive
- Diagnosed with CHB defined as HBsAg positive for at least 6 months prior to Screening and Baseline
- Has received treatment with a NUC (entecavir, tenofovir disoproxil fumarate and tenofovir alafenamide) for at least 6 months
- Female subjects must be surgically sterile, postmenopausal or if of childbearing potential must have a negative pregnancy test and must be willing to use a highly effective form of contraception
- Male subjects must be surgically sterile, abstinent, agree to use an appropriate contraception
Exclusion Criteria12
- Participants that meet any of the following criteria are not eligible to proceed into the Treatment
- Period.
- Participants with any evidence of liver disease of non-HBV etiology.
- Previous history or current diagnosis of significant liver fibrosis or cirrhosis as evidenced by:
- Liver biopsy
- History of or suspected hepatocellular carcinoma
- Positive testing for HIV-1, HIV-2, HCV, or HDV that suggests a concurrent infection.
- Immunodeficient or autoimmune conditions due to disease e.g., thyroid or kidney disease or medication requiring systemic steroids within the previous 12 weeks (topical or inhaled steroids are permissible).
- Chronic treatment with immunosuppressant
- Cancer or treatment for cancer within 3 years before Screening. Successfully treated basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ are allowed.
- History of anaphylaxis, hypersensitivity, or significant drug allergies.
- Any condition that in the investigator's opinion might interfere with study objectives.
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Interventions
This Phase 1b study is the first study of CLB-3000, a bivalent subunit vaccine adjuvanted with Alhydrogel®, in participants with chronic hepatitis B (CHB). Investigational Product: CLB-3000 (a bivalent, subunit vaccine comprised of CLB-405 and CLB-505 adjuvanted with Alhydrogel) Route of Administration: Intramuscular Injection by study staff at the clinic Study Duration: Approximately 11 months, including up to 28 days in screening, 5 monthly injections of study drug at Days 0, 30, 60, 90, 120 and a 6-month follow-up period through Day 300. This study is designed to assess the safety, tolerability, immunogenicity, and antiviral activity of repeated administration of two dose levels of CLB-3000 in adults with CHB taking stable doses of standard of care nucleoside/nucleotide analogues (NUCs) for viral suppression. . Patients will be enrolled in one cohort only. Dose levels planned are CLB-3000 200 µg and CLB-3000 500 µg with a separate optional expansion cohort at the highest dose studied as the third cohort. The highest dose will be 500 µg for the study. That will be the dose studied in Cohort 2 and in the expansion cohort unless a lower dose is indicated based on ongoing review of safety data.
Locations(8)
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ACTRN12623000841673