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Trial registered on ANZCTR


Registration number
ACTRN12623000841673
Ethics application status
Approved
Date submitted
14/07/2023
Date registered
4/08/2023
Date last updated
1/11/2023
Date data sharing statement initially provided
4/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Study to Evaluate the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in participants with Chronic Hepatitis B
Scientific title
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
Secondary ID [1] 309767 0
CLB-3000-1-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 330171 0
Condition category
Condition code
Oral and Gastrointestinal 327047 327047 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 327597 327597 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326323 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334907 0
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
Timepoint [1] 334907 0

Vital Signs will be collected at Screening, Day 1 (day of first dose), and Day 15, Day 30, Day 45, Day 60, Day 90, Day 120, Day 150 (Safety follow-up visit) and Day 300 (End of study visit) after first dose of study drug
Weight will be collected at Screening, Day 1 (day of first dose), Day 60, and Day 120 after first dose of study drug.
Complete physical examination will be done at screening and Day 1 (day of first dose) and Day 150 (safety follow up visit) after first dose of study drug
Targeted physical examination will be done at Day 30, 60, 90, 120 and 300 after first dose of study drug.
Adverse Event Collection will occur at Screening, Day 1 (day of first dose), and Day 15, Day 30, Day 45, Day 60, Day 75 (telephone visit), Day 90, Day 105 (telephone visit), Day 120, Day 150 (Safety follow-up visit) and Day 300 (End of study visit) after first dose of study drug
Clinical laboratory parameters will be collected at Screening, Day 1 (day of first dose), and Day 15, Day 30, Day 45, Day 60, Day 90, Day 120, Day 150 (Safety follow-up visit) and Day 300 (End of study visit) after first dose of study drug.
Urinalysis will be done at Screening Day 1 (first dose of study drug), and Day 30, Day 60, Day 90, Day 120, Day 150 (Safety follow-up visit) and Day 300 (End of study visit) after first dose of study drug
Electrocardiogram measurements will be collected at Screening, Day 1 (day of first dose), and Day 30, Day 60, Day 90, Day 120, Day 150 (Safety follow-up visit) and Day 300 (End of study visit) after first dose of study drug
Secondary outcome [1] 422430 0
To evaluate the immunogenicity of CLB-3000 by measuring serum antibodies to CLB-405 and CLB-505
Timepoint [1] 422430 0
Blood samples will be collected on Day 1 (day of first dose), and Day 15, Day 30, Day 60, Day 90, Day 120, Day 150 (Safety follow-up visit) and Day 300 (End of study visit) after first dose of study drug
Secondary outcome [2] 422433 0
To evaluate the antiviral activity of CLB-3000 as measured by serum HBsAg levels.
Timepoint [2] 422433 0
Blood samples will be collected at the screening, Day 1 (day of first dose), and Day 15, Day 30, Day 60, Day 90, Day 120, Day 150 (Safety follow up visit) and Day 300 (end of study visit) after first dose of study drug
Secondary outcome [3] 422435 0
To assess the effect of CLB-3000 on other biomarkers. This is exploratory outcome
Timepoint [3] 422435 0
Blood samples will be collected at the screening, and Day 1 (day of first dose) and Day 15, Day 30, Day 60, Day 90, Day 120, Day 150 (Safety follow up visit) and Day 300 (end of study visit) after first dose of study drug
Secondary outcome [4] 422959 0
To assess the effect of CLB-3000 on immunological biomarkers. These are exploratory.
Timepoint [4] 422959 0
Blood samples will be collected on Day 1 (day of first dose), and Day 30, Day 90 and Day 120 after first dose of study drug. These are exploratory.

Eligibility
Key inclusion criteria
1. Able to give written informed consent.
2. Age 18 to 60 years, inclusive
3. Diagnosed with CHB defined as HBsAg positive for at least 6 months prior to Screening and Baseline
4. Has received treatment with a NUC (entecavir, tenofovir disoproxil fumarate and tenofovir alafenamide) for at least 6 months
5. 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
6. Male subjects must be surgically sterile, abstinent, agree to use an appropriate contraception
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants that meet any of the following criteria are not eligible to proceed into the Treatment
Period.
1. Participants with any evidence of liver disease of non-HBV etiology.
2. Previous history or current diagnosis of significant liver fibrosis or cirrhosis as evidenced by:
Liver biopsy
3. History of or suspected hepatocellular carcinoma
4. Positive testing for HIV-1, HIV-2, HCV, or HDV that suggests a concurrent infection.
5. 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).
6. Chronic treatment with immunosuppressant
7. 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.
8. History of anaphylaxis, hypersensitivity, or significant drug allergies.
9. Any condition that in the investigator's opinion might interfere with study objectives.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/09/2023
Actual
11/09/2023
Date of last participant enrolment
Anticipated
18/12/2024
Actual
Date of last data collection
Anticipated
18/12/2025
Actual
Sample size
Target
12
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24908 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 25115 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 25116 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 25119 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 25120 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [6] 25121 0
Nepean Hospital - Kingswood
Recruitment hospital [7] 25122 0
Concord Repatriation Hospital - Concord
Recruitment hospital [8] 25123 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 40783 0
2050 - Camperdown
Recruitment postcode(s) [2] 40789 0
2139 - Concord
Recruitment postcode(s) [3] 40788 0
2747 - Kingswood
Recruitment postcode(s) [4] 40560 0
3065 - Fitzroy
Recruitment postcode(s) [5] 40786 0
3128 - Box Hill
Recruitment postcode(s) [6] 40782 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 40787 0
4575 - Birtinya
Recruitment postcode(s) [8] 40790 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 313955 0
Commercial sector/Industry
Name [1] 313955 0
ClearB Therapeutics, Inc.
Country [1] 313955 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
ClearB Therapeutics, Inc.
Address
530 Virginia Road, Suite 300, Concord, Massachusetts 01742, United States
Country
United States of America
Secondary sponsor category [1] 315822 0
Commercial sector/Industry
Name [1] 315822 0
Novotech Australia Pty Ltd
Address [1] 315822 0
Level 3, 235 Pyrmont Street Sydney, NSW Australia - 2009
Country [1] 315822 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313092 0
St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 313092 0
41 Victoria Parade Fitzroy, PO Box 2900 Fitzroy VIC 3065
Ethics committee country [1] 313092 0
Australia
Date submitted for ethics approval [1] 313092 0
Approval date [1] 313092 0
05/05/2023
Ethics approval number [1] 313092 0

Summary
Brief 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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126974 0
Prof Alexander Thompson
Address 126974 0
St Vincent’s Hospital Melbourne
41 Victoria Parade, Fitzroy VIC 3065, Australia
Country 126974 0
Australia
Phone 126974 0
+61 3 9231 3581
Fax 126974 0
Email 126974 0
alexander.thompson@svha.org.au
Contact person for public queries
Name 126975 0
Prof Alexander Thompson
Address 126975 0
St Vincent’s Hospital Melbourne
41 Victoria Parade, Fitzroy VIC 3065, Australia
Country 126975 0
Australia
Phone 126975 0
+61 3 9231 3581
Fax 126975 0
Email 126975 0
alexander.thompson@svha.org.au
Contact person for scientific queries
Name 126976 0
Prof Alexander Thompson
Address 126976 0
St Vincent’s Hospital Melbourne
41 Victoria Parade, Fitzroy VIC 3065, Australia
Country 126976 0
Australia
Phone 126976 0
+61 3 9231 3581
Fax 126976 0
Email 126976 0
alexander.thompson@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.