None listed
Conditions
Brief summary
Summary A Phase 1b Study Evaluating the Safety and Tolerability of CLB-4000 with or without Peg-IFNa-2a in Subjects with Chronic Hepatitis B Who is it for? You may be eligible for this study if you are an adult aged between 18 and 60 years old with chronic hepatitis B. Participants in this study will be randomly allocated (by chance) to one of two treatments: - Arm 1: CLB-4000 (250 µg CLB-405 and 250 µg CLB-505 adjuvanted with 400 µg TQL-1055), or - Arm 2: CLB-4000 (250 µg CLB-405 and 250 µg CLB-505 adjuvanted with 200 µg TQL-1055) with 180 µg Peg-IFNa-2a Eligible participants will receive 5 monthly Intramuscular (IM) injections of CLB-4000 on Days 1, 30, 60, 90, and 120. Subjects participating in arm 2 will self-administer or have a caregiver administer a weekly subcutaneous injection of Peg-IFNa-2a 180 mcg for 8 weeks during a run-in period and then for 16 weeks during the CLB-4000 treatment phase following injection training and instructions on proper storage and disposal by a clinician. 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 or, for subjects participating in Peg-IFNa-2a arms, 13 months.
Interventions
This study has 3 cohorts and one optional cohort, Eligible participants will receive 5 monthly Intramuscular (IM) injections of CLB-4000 on Days 1, 30, 60, 90, and 120. This registration is for cohort 2 (randomised cohort) with other cohorts registered under ACTRN12625000204448. Subjects participating in Peg-IFNa-2a arms of the study will receive a weekly subcutaneous injection of Peg-IFNa-2a 180 µg for 8 weeks during a run-in period and then for another 16 weeks during the CLB-4000 treatment p
This study has 3 cohorts and one optional cohort, Eligible participants will receive 5 monthly Intramuscular (IM) injections of CLB-4000 on Days 1, 30, 60, 90, and 120. This registration is for cohort 2 (randomised cohort) with other cohorts registered under ACTRN12625000204448. Subjects participating in Peg-IFNa-2a arms of the study will receive a weekly subcutaneous injection of Peg-IFNa-2a 180 µg for 8 weeks during a run-in period and then for another 16 weeks during the CLB-4000 treatment phase. Cohort 2 (N=8): subjects randomized 1:1 to two arms: Arm 1- CLB-4000 (250 µg CLB-405 and 250 µg CLB-505 adjuvanted with 400 µg TQL-1055) Arm 2- CLB-4000 (250 µg CLB-405 and 250 µg CLB-505 adjuvanted with 200 µg TQL-1055) with 180 µg Peg-IFNa-2a The intervention (CLB-4000) is administered at the trial site and is recorded in the eCRF. Each Peg-IFNa-2a dose administration is recorded on a patient diary and includes dosing date, time, if it was self-administered or administered by a caregiver and if the full volume was administered. The diary will be review at clinic visits. to check on adherence to the intervention.
Sponsors
ClearB Therapeutics, Inc.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Able to give written informed consent. 2. Age 18 to 60 years, inclusive 3. Body mass index (BMI) 18 to 35 kg/m2. 4. Diagnosed with CHB for at least 6 months and a HBsAg greater than 100 IU/mL and less than 500 IU/mL.. 5.Anti-HBs antibodies <2.0 IU/L. 6. Serum HBV DNA <20 IU/mL for more than equal to 6 months and HBV DNA <20 IU/mL at screening 7. Has received treatment with a NUC (entecavir, tenofovir disoproxil fumarate and tenofovir alafenamide) for at least 6 months 8. Female subjects must be surgically sterile, postmenopausal or if of childbearing potential must have a negative pregnancy test and must be willing to use highly effective forms of contraception. 9. Male subjects must be surgically sterile, abstinent, agree to use an appropriate contraception.
Exclusion criteria
1. Participants with any evidence of liver disease of non-HBV etiology. 2. Previous history or current diagnosis of significant liver fibrosis or cirrhosis 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 within 30 days before run-in or study drug administration at the Day 1 visit and throughout the duration of study participation. 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. 10. Contraindications to the use of Peg-IFNa-2a or incapable of self-administration or assisted administration of Peg-IFNa-2a (Peg-IFNa-2a enrolling arms) 11. Subjects with pre-existing ophthalmologic disorders (Peg-IFNa-2a enrolling arms)
Outcome results
None listed