A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Placebo-controlled, Single-Ascending Dose Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: HH-006
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HH-006<br> | Drug: HH-006<br>* Different dose levels of HH-006<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Different dose levels of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |