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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB06-036 in Subjects With Chronic Hepatitis B | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB06-036 in Subjects With Chronic Hepatitis B

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of CB06-036 in Subjects With Chronic Hepatitis B

NCT05828745•Shanghai Zhimeng Biopharma, Inc.

View on ClinicalTrials.gov

Summary

CB06-036 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Provide written informed consent before any study assessment is performed. 2. Male or nonpregnant, nonlactating female between the ages of 18 and 65 years (inclusive) at screening.
•Females of childbearing potential (as defined in Appendix 3) must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test at baseline prior to enrollment and agree to use 2 methods of birth control. Methods must include 1 highly effective method with a secondary method of birth control during the study and for 3 months following the last dose of CB06-036. These methods are defined in Appendix 3.
•Note: Females must agree not to breastfeed during the study and 30 days after receiving the last administration of CB06-036 and not to donate eggs (ova, oocytes) for assisted reproduction during the study and 90 days after receiving the last administration of CB06-036. Females of nonchildbearing potential defined as permanently sterile (ie, due to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal, as defined in Appendix 3.
•Males with a female partner(s) of childbearing potential will agree to use contraception as detailed in Appendix 3. Male subjects must not donate sperm during the study and for at least 90 days after the last administration of CB06-036.
•3\. Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6 months) with detectable HBsAg level at screening. Cohort 4 only: qHBsAg should be \<3000 IU/mL.
•4\. Have been on commercially available HBV NA treatment(s) (tenofovir alafenamide, tenofovir disoproxil fumarate, entecavir, either as a single agent or in combination) for at least 6 months with no change in regimen for 3 months prior to screening.
•5\. HBV DNA \<90 IU/mL; measured at least once by local laboratory assessment within 6 months prior to screening.
•6\. HBV DNA \<90 IU/mL at screening. 7. Body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive), and a total body weight ≥50.0 kg for males and ≥45.0 kg for females at screening.
•8\. Electrocardiogram (ECG) without clinically significant abnormalities and with QT interval corrected using Fridericia's formula (QTcF) ≤450 msec for males and ≤470 msec for females at screening.
•9\. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.

Exclusion Criteria

•1\. CHB patients with extensive bridging fibrosis or cirrhosis (METAVIR ≥3 or Ishak ≥4 by a liver biopsy within 5 years, FibroTest score \>0.48 and APRI \>1, or a historic FibroScan \>9 kPa within 6 months prior to screening).
•2\. Subjects met any of the following laboratory parameters at screening:
•1. hemoglobin \<12 g/dL (for males) or \<11 g/dL (for females)
•2. white blood cell count \<2500 cells/mm3 Protocol CONFIDENTIAL Labcorp Drug Development Study: 000000244098 Protocol Reference: CB06-036-102 Protocol Version 1.0, 24 January 2023 Page 8 of 68
•3. neutrophil count \<1500 cells/mm3 (or \<1000 cells/mm3 if considered a physiological variant in a subject of African descent)
•4. ALT \>2 × ULN
•5. INR \>ULN unless the subject is stable on an anticoagulant regimen affecting INR
•6. albumin \<3.5 g/dL
•7. direct bilirubin \>1.5 × ULN
•8. platelet Count \<100,000/μL
+23 more criteria

Locations (2)

First Hospital of Jilin University

Changchun, Jilin, China

PCRN Trials Limited, trading as PCRN Auckland, Level 2, 2 Fred Thomas Drive, Takapuna, Auckland, 0622, New Zealand (hereinafter referred to as "Institution")

Auckland, New Zealand

Key Dates

Start Date

April 22, 2024

Primary Completion Date

February 18, 2025

Completion Date

February 18, 2025

Last Updated

May 21, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis b

Interventions

CB06-036

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB06-036 in Subjects With Chronic Hepatitis B

Inclusion Criteria

Exclusion Criteria

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