Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HH-006 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HH-006 | Drug | Different dose levels of HH-006 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events (TEAEs) | An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs. | Day 1- Day 113 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed HH-006 concentration | Day 1-Day 113 |
| Tmax | Time to maximum observed HH-006 concentration | Day 1-Day 113 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jason Lickliter | Nucleus Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm Pty Ltd (Nucleus Network Pty Ltd) | Brisbane | Queensland | 4006 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Different dose levels of placebo |
|
| AUC0- last | Area under the plasma concentration-time curve from time zero to the last time point with measurable concentration | Day 1-Day 113 |
| AUC0-inf | AUC from time zero extrapolated to infinity | Day 1- Day 113 |
| t1/2 | Apparent terminal half-life | Day 1- Day 113 |
| CL (SAD) | Apparent total body clearance | Day 1-Day 113 |
| CL/F (SAD) | Apparent clearance | Day 1-Day 113 |
| Vz/F (SAD) | Apparent terminal volume of distribution | Day 1-Day 113 |
| Titres of anti drug antibodies (ADA) to HH-006 | To determine the immunogenicity of HH-006 | Day 1- Day 113 |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |