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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05770895
Other study ID # GS-US-642-5670
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date April 3, 2023
Est. completion date January 2025

Study information

Verified date April 2024
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical study is to learn more about GS-2829 and GS-6779 in healthy participants and participants with CHB.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 83
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Biological:
GS-2829
Administered intramuscularly
GS-6779
Administered intramuscularly
Placebo for GS-2829
Administered intramuscularly
Placebo for GS-6779
Administered intramuscularly

Locations

Country Name City State
New Zealand New Zealand Clinical Research (NZCR) Auckland
Taiwan Chia-Yi Christian Hospital Chiayi City
Taiwan St. Martin De Porres Hospital Chiayi City
Taiwan Kaohsiung Medical University Hospital Kaohsiung
Taiwan Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital Kaohsiung City
Taiwan E-DA Hospital Kaohsiung City
Taiwan National Cheng Kung University Hospital Tainan City
Taiwan National Taiwan University Hospital Taipei City
Taiwan Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital Taoyuan City

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

New Zealand,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) First dose date to end of study followed up to 24 weeks post last dose (Up to Day 225 for Cohorts 1 and 2; Up to Day 309 for Cohorts 3-8)
Primary Percentage of Participants With Treatment-emergent Laboratory Abnormalities First dose date to end of study followed up to 24 weeks post last dose (Up to Day 225 for Cohorts 1 and 2; Up to Day 309 for Cohorts 3-8)
Secondary Proportion of Participants With Vaccine-induced Immune Response First dose date to end of study followed up to 24 weeks post last dose (Up to Day 225 for Cohorts 1 and 2; Up to Day 309 for Cohorts 3-8)
Secondary Magnitude of Vaccine-Induced Immune Responses as Measured by T-Cell Levels (T-Cell Responses to HBV) First dose date to end of study followed up to 24 weeks post last dose (Up to Day 225 for Cohorts 1 and 2; Up to Day 309 for Cohorts 3-8)
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