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.0 个研究点目标入组 12 人开始时间: 2023年8月4日最近更新: 2024年8月19日

适应症

试验速览

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•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

•Participants that meet any of the following criteria are not eligible to proceed into the Treatment
•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.

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