Hepatitis B
Conditions
Brief summary
Huahui Health is developing a treatment for Hepatitis B virus. This study is designed to evaluate the safety and tolerability of HH-006, a hepatitis virus neutralizing monoclonal antibody in healthy volunteers, and to determine its pharmacokinetic profile and immunogenicity.
Detailed description
This is a double-blind, placebo-controlled, Phase Ia study aimed to evaluate the safety and tolerability of HH-006 after single ascending doses given as subcutaneous injections.
Interventions
DRUGHH-006
Different dose levels of HH-006
DRUGPlacebo
Different dose levels of placebo
Sponsors
Huahui Health
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Generally healthy male or female individuals aged between 18 to 65 years old * A bodyweight ≥ 45 kg and the body mass index (BMI) is between 18 to 32 kg/m2.
Exclusion criteria
* History of anaphylaxis or other significant allergy in the opinion of the Investigator or known allergy or hypersensitivity to any of the components of the IP * History of drug, alcohol, or substance abuse * Any history of liver disease or known hepatic, or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) * Any history of anaphylaxis, severe allergic reaction, neutralizing antibody generations, or hypersensitivity to albumin or any protein-based therapeutics such as natalizumab (Tysabri) or any other monoclonal antibodies * Any previous exposure to chimeric, humanized, or human monoclonal antibody, whether licensed or not * Medical history of active infection (acute or chronic) * Any safety concern or personal condition that is inappropriate for the study participation per the Investigator's judgement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment emergent adverse events (TEAEs) | Day 1- Day 113 | An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs. |
| Severity of treatment emergent adverse events as measured by CTCAE v 5.0 | Day 1- Day 113 | — |
| Duration of treatment emergent adverse events | Day 1- Day 113 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-inf | Day 1- Day 113 | AUC from time zero extrapolated to infinity |
| t1/2 | Day 1- Day 113 | Apparent terminal half-life |
| CL (SAD) | Day 1-Day 113 | Apparent total body clearance |
| Cmax | Day 1-Day 113 | Maximum observed HH-006 concentration |
| Vz/F (SAD) | Day 1-Day 113 | Apparent terminal volume of distribution |
| Titres of anti drug antibodies (ADA) to HH-006 | Day 1- Day 113 | To determine the immunogenicity of HH-006 |
| CL/F (SAD) | Day 1-Day 113 | Apparent clearance |
| Tmax | Day 1-Day 113 | Time to maximum observed HH-006 concentration |
| AUC0- last | Day 1-Day 113 | Area under the plasma concentration-time curve from time zero to the last time point with measurable concentration |
Countries
Australia
Outcome results
None listed