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

NCT05828745 | Completed Phase 1 DMC

• 1 other identifier: CB06-036-102
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Chronic Hepatitis b

Keywords

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of CB06-036 following multiple oral dose administration of CB06-036 in virally suppressed subjects with CHB.

  Number of participants with treatment-related adverse events as assessed by CTCAE V5.0 or higher

  From the date the first subject signs an informed consent form to the date of the last subject's last assessment (scheduled or unscheduled).

Secondary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of CB06-036 following multiple oral dose administration in virally suppressed subjects with CHB.

  From 30 minutes pre-dose to 24 hours post-dose

• Area Under the Plasma Concentration Versus Time Curve (AUC) of CB06-036

  From 30 minutes pre-dose to 24 hours post-dose

• The following inflammatory cytokines and chemokines will be analyzed in serum: CCL11 (Eotaxin-1), CCL2 (MCP1), CCL20 (MIP3α), CCL4 (MIP1ß), CCL8 (MCP2), CRP, CXCL10 (IP10), CXCL8 (IL-8), CXCL9 (MIG), IFN-γ, IL-12p40, IL-12p70, IL-1RA, SAA, TNF-α

  From pre-dose to 72 hours post-dose of the last dose of study drug

Study Arms (6)

CB06-036 Cohort 1

EXPERIMENTAL

CB06-036 1.5 mg once weekly

Drug: CB06-036

Placebo Cohort 1

PLACEBO COMPARATOR

Placebo 1.5 mg once weeky

Drug: Placebo

CB06-036 Cohort 2

EXPERIMENTAL

CB06-036 3.0 mg once weekly

Drug: CB06-036

Placebo Cohort 2

PLACEBO COMPARATOR

Placebo 3.0 mg once weekly

Drug: Placebo

CB06-036 Cohort 3

EXPERIMENTAL

CB06-036 1.5 mg twice-a-week, for 4 weeks

Drug: CB06-036

Placebo Cohort 3

PLACEBO COMPARATOR

Placebo 3.0 mg twice-a-week, for 4 weeks

Drug: Placebo

Interventions

CB06-036 DRUG

CB06-036 capsule

CB06-036 Cohort 1; CB06-036 Cohort 2; CB06-036 Cohort 3

Placebo DRUG

Placebo capsule

Placebo Cohort 1; Placebo Cohort 2; Placebo Cohort 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. HBV DNA \<90 IU/mL; measured at least once by local laboratory assessment within 6 months prior to screening.
• \. 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.
• \. 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.
• \. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.

You may not qualify if:

• \. 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).
• \. Subjects met any of the following laboratory parameters at screening:
• hemoglobin \<12 g/dL (for males) or \<11 g/dL (for females)
• 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
• neutrophil count \<1500 cells/mm3 (or \<1000 cells/mm3 if considered a physiological variant in a subject of African descent)
• ALT \>2 × ULN
• INR \>ULN unless the subject is stable on an anticoagulant regimen affecting INR
• albumin \<3.5 g/dL
• direct bilirubin \>1.5 × ULN
• platelet Count \<100,000/μL
• estimated creatinine clearance (CrCl) \<60 mL/min (using the Cockcroft-Gault method).
• Active systemic infections (other than common cold) within 2 weeks before randomization.
• At screening, known history of lymphoma, leukemia, or malignancy within the past 5 years, except for squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
• History or suspicion of hepatocellular carcinoma (ie, elevated alpha fetoprotein (AFP) \>50 ng/mL; suggestive lesions on abdominal ultrasound or other imaging).
• History or presence of a medical condition associated with liver disease other than HBV infection (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, moderate to severe nonalcoholic steatohepatitis). Other known clinically significant hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

Sponsors & Collaborators

• Shanghai Zhimeng Biopharma, Inc.: lead

Study Sites (2)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

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

Auckland, 0622, New Zealand

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 25, 2023
• Study Start: April 22, 2024
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: May 21, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); NZ (1)