Chronic Hepatitis bPhase 1NCT05828745
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB06-036 in Subjects With Chronic Hepatitis B
A Phase 1 study testing CB06-036 in people with Chronic Hepatitis b, run by Shanghai Zhimeng Biopharma, Inc. at 2 sites in 2 countries.
Trial summary
CB06-036 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- CB06-036
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Apr 2024to 18 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
- 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
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- 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).
- 3.Active systemic infections (other than common cold) within 2 weeks before randomization.
- 4.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.
- 5.History or suspicion of hepatocellular carcinoma (ie, elevated alpha fetoprotein (AFP) >50 ng/mL; suggestive lesions on abdominal ultrasound or other imaging).
- 6.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).
- 7.History of transaminase (ALT and/or AST) flare in the previous 6 months prior to study enrollment.
- 8.Personal or familial history or symptomatology indicative of a risk of immune mediated disease (eg, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis, autoimmune uveitis, multiple sclerosis).
- 9.Received a solid organ or bone marrow transplant. 10.Received prolonged systemic therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening.
- 11.Blood donation of approximately 500 mL within 56 days prior to first administration of study drug, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- 12.Have a known history of asthma. Note: Subjects with resolved childhood asthma with no history of hospitalization due to asthma are allowed.
- 13.Current use of strong and moderate CYP3A4 inhibitors or inducers; please see Appendix 6 for a list.
- 14.Are currently enrolled in, or discontinued from, a clinical trial involving an investigational product or non-approved drug within the last 4 weeks or at least 5 half-lives of the last dosing, if the half-life of the investigational product or non-approved drug is greater than 5 days; or concurrently enrolled in any other types of medical research judged not to be scientifically or medically compatible with this study.
- 15.live vaccination during the course of the study, or have participated in a vaccine clinical trial within 12 weeks prior to randomization. Investigators should review the vaccination status of the subjects and follow the local guidelines for adult vaccination with non-live vaccines intended to prevent infectious disease prior to administration of study drug.
- 16.Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV).
- Subjects who are HCV Ab positive, but have a documented negative HCV RNA, are eligible.
- 17.Abnormal clinical laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the subject or of interfering with the interpretation of study results if participating in the study.
- 18.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test at screening or at Days -7 to -4.
- 19.Have any other condition that precludes the subject from following and completing the protocol in the opinion of the investigator.
- 20.Significant history or clinical manifestation of any metabolic, allergic, dermatologic, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, retinal, or psychiatric disorder, as determined by the investigator (or designee).
- 21.History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- 22.Use or intend to use any nonprescription medications or products including vitamins, minerals, and herbal supplements (ie, traditional Chinese medicine), protein powders or fish oils preparations within 7 days prior to screening, considered to potentially impact subject safety or the objectives of the study, as determined by the investigator (or designee).
- 23.Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
- 24.Ingestion of Seville orange or grapefruit-containing foods or beverages within 7 days prior to screening.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
New Zealand1 site
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
About this study
Official title: 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
CB06-036 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.
- Conditions
- Chronic Hepatitis b
- Being tested
- CB06-036, Placebo
- Keywords
- Chronic Hepatitis b
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB06-036Drug
CB06-036 capsule
PlaceboDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| CB06-036 Cohort 1 | Experimental | CB06-036 1.5 mg once weekly Receives: Drug: CB06-036 |
| Placebo Cohort 1 | Placebo comparator | Placebo 1.5 mg once weeky Receives: Drug: Placebo |
| CB06-036 Cohort 2 | Experimental | CB06-036 3.0 mg once weekly Receives: Drug: CB06-036 |
| Placebo Cohort 2 | Placebo comparator | Placebo 3.0 mg once weekly Receives: Drug: Placebo |
| CB06-036 Cohort 3 | Experimental | CB06-036 1.5 mg twice-a-week, for 4 weeks Receives: Drug: CB06-036 |
| Placebo Cohort 3 | Placebo comparator | Placebo 3.0 mg twice-a-week, for 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Plasma will be collected at multiple timepoints from within 30 minutes pre-dose to 24 hours post-dose
Measured: From 30 minutes pre-dose to 24 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of CB06-036
Cohort1 \& Cohort2: Plasma will be collected on Day 1 and Day 22 at multiple timepoints from within 30 minutes pre-dose to 24 hours post-dose.
Cohort 3: Plasma will be collected on Day 1 and Day 25 at multiple timepoints from within 30 minutes pre-dose to 24 hours post-dose.
Measured: 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
Cohort1 \& Cohort2: Blood samples will be collected on Day 1 and Day 22 at pre-dose and 2, 4, 8, 12, 48, and 72 hours post-dose.
Cohort3: Blood samples for the PD of CB06-036 will be collected on Day 1 and Day 25 at pre-dose and 2, 4, 8, 12, and 48 hours post-dose. Also, the samples will be collected at Day 4 at pre-dose and 4 hours (peak) post-dose.
Measured: From pre-dose to 72 hours post-dose of the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start22 Apr 2024
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhimeng Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828745
- Sponsor's protocol ID
- CB06-036-102
- Status last verified
- Aug 2024
- First submitted
- 12 Apr 2023
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05828745
- Acronym / sponsor ID
- CB06-036-102
- Conditions
- Chronic Hepatitis b
- Keywords
- Chronic Hepatitis b
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai Zhimeng Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CB06-036 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CB06-036 Cohort 1 | Experimental | Drug: CB06-036CB06-036 1.5 mg once weekly |
| Placebo Cohort 1 | Placebo comparator | Drug: PlaceboPlacebo 1.5 mg once weeky |
| CB06-036 Cohort 2 | Experimental | Drug: CB06-036CB06-036 3.0 mg once weekly |
| Placebo Cohort 2 | Placebo comparator | Drug: PlaceboPlacebo 3.0 mg once weekly |
| CB06-036 Cohort 3 | Experimental | Drug: CB06-036CB06-036 1.5 mg twice-a-week, for 4 weeks |
| Placebo Cohort 3 | Placebo comparator | Drug: PlaceboPlacebo 3.0 mg twice-a-week, for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (33 listed)
- 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).
- 3.Active systemic infections (other than common cold) within 2 weeks before randomization.
- 4.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.
- 5.History or suspicion of hepatocellular carcinoma (ie, elevated alpha fetoprotein (AFP) >50 ng/mL; suggestive lesions on abdominal ultrasound or other imaging).
- 6.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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CB06-036CB06-036 capsule | Drug | CB06-036 Cohort 1, CB06-036 Cohort 2, CB06-036 Cohort 3 |
| PlaceboPlacebo capsule | Drug | Placebo Cohort 1, Placebo Cohort 2, Placebo Cohort 3 |
Primary outcome
To evaluate the safety and tolerability of CB06-036 following multiple oral dose administration of CB06-036 in virally suppressed subjects with CHB.
Time frame: From the date the first subject signs an informed consent form to the date of the last subject's last assessment (scheduled or unscheduled).
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0 or higher
3 secondary outcomes
Maximum Plasma Concentration (Cmax) of CB06-036 following multiple oral dose administration in virally suppressed subjects with CHB.
Time frame: From 30 minutes pre-dose to 24 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of CB06-036
Time frame: 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
Time frame: From pre-dose to 72 hours post-dose of the last dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CB06-036 in people with Chronic Hepatitis b, run by Shanghai Zhimeng Biopharma, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of CB06-036 following multiple oral dose administration of CB06-036 in virally suppressed subjects with CHB. (time frame: From the date the first subject signs an informed consent form to the date of the last subject's last assessment (scheduled or unscheduled).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.