Q-Pharm Pty Ltd (Nucleus Network Pty Ltd)
Brisbane, Queensland, 4006, Australia
NCT Number: NCT05275465
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Brisbane, Queensland, 4006, Australia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Different dose levels of HH-006
Different dose levels of placebo
Time frame: 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.
Time frame: Day 1- Day 113
Time frame: Day 1- Day 113
Time frame: Day 1-Day 113
Maximum observed HH-006 concentration
Time frame: Day 1-Day 113
Time to maximum observed HH-006 concentration
Time frame: Day 1-Day 113
Area under the plasma concentration-time curve from time zero to the last time point with measurable concentration
Time frame: Day 1- Day 113
AUC from time zero extrapolated to infinity
Time frame: Day 1- Day 113
Apparent terminal half-life
Time frame: Day 1-Day 113
Apparent total body clearance
Time frame: Day 1-Day 113
Apparent clearance
Time frame: Day 1-Day 113
Apparent terminal volume of distribution
Time frame: Day 1- Day 113
To determine the immunogenicity of HH-006
Huahui Health
Industry
A Randomized, Placebo-controlled, Single-Ascending Dose Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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