Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT05770895
Eligibility Criteria:
Key Inclusion Criteria:
Phase 1a and 1b:
* Body mass index (BMI) of ≤ 32.0 kg/m\^2.
* Non-diabetic without impaired glucose tolerance.
* No evidence of cardiac disease based on 12 lead ECG.
Phase 1a (Healthy Individuals) only:
* Aged 18 through 60 years.
* No history of Hepatitis B infection with a negative Hepatitis B virus (HBV) core Antibody.
Phase 1b (Virally suppressed CHB individuals):
* Aged 18 through 65 years.
* Documented CHB and HBsAg ≤ 5000 IU/mL at screening.
* No evidence of advanced fibrosis by Fibroscan (defined as Fibroscan \< 9 kPa within 6 months of screening).
* Diagnosed with chronic hepatitis B on suppressive oral antiviral for ≥ 6 months.
Key Exclusion Criteria:
Phase 1a and 1b:
* Use of any systemic antibiotics within 30 days of screening.
* Receipt of any HBV vaccine within 12 months of screening visit or planning HBV vaccination during the study period.
* Receipt of any investigational product within 3 months or vaccine within 3 months of screening (with the exception of influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, which if needed, should be administered at least 14 days before or after an investigational product administration).
* Receipt of immunoglobulin or other blood products within 3 months of screening.
* Positive serum pregnancy test at screening or positive urine pregnancy on Day 1.
* Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, other immune or cytokine-based therapies).
* Participation in any other clinical study (including observational studies) without prior approval from the sponsor is prohibited while participating in the study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05770895
Study Brief:
Protocol Section:
NCT05770895