A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
HH-006
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B
Eligibility Criteria
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.
Sites / Locations
- Q-Pharm Pty Ltd (Nucleus Network Pty Ltd)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HH-006
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Severity of treatment emergent adverse events as measured by CTCAE v 5.0
Duration of treatment emergent adverse events
Secondary Outcome Measures
Cmax
Maximum observed HH-006 concentration
Tmax
Time to maximum observed HH-006 concentration
AUC0- last
Area under the plasma concentration-time curve from time zero to the last time point with measurable concentration
AUC0-inf
AUC from time zero extrapolated to infinity
t1/2
Apparent terminal half-life
CL (SAD)
Apparent total body clearance
CL/F (SAD)
Apparent clearance
Vz/F (SAD)
Apparent terminal volume of distribution
Titres of anti drug antibodies (ADA) to HH-006
To determine the immunogenicity of HH-006
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05275465
Brief Title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
Official Title
A Randomized, Placebo-controlled, Single-Ascending Dose Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
December 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huahui Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HH-006
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HH-006
Intervention Description
Different dose levels of HH-006
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Different dose levels of placebo
Primary Outcome Measure Information:
Title
Number of participants with treatment emergent adverse events (TEAEs)
Description
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
Title
Severity of treatment emergent adverse events as measured by CTCAE v 5.0
Time Frame
Day 1- Day 113
Title
Duration of treatment emergent adverse events
Time Frame
Day 1- Day 113
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum observed HH-006 concentration
Time Frame
Day 1-Day 113
Title
Tmax
Description
Time to maximum observed HH-006 concentration
Time Frame
Day 1-Day 113
Title
AUC0- last
Description
Area under the plasma concentration-time curve from time zero to the last time point with measurable concentration
Time Frame
Day 1-Day 113
Title
AUC0-inf
Description
AUC from time zero extrapolated to infinity
Time Frame
Day 1- Day 113
Title
t1/2
Description
Apparent terminal half-life
Time Frame
Day 1- Day 113
Title
CL (SAD)
Description
Apparent total body clearance
Time Frame
Day 1-Day 113
Title
CL/F (SAD)
Description
Apparent clearance
Time Frame
Day 1-Day 113
Title
Vz/F (SAD)
Description
Apparent terminal volume of distribution
Time Frame
Day 1-Day 113
Title
Titres of anti drug antibodies (ADA) to HH-006
Description
To determine the immunogenicity of HH-006
Time Frame
Day 1- Day 113
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Lickliter
Organizational Affiliation
Nucleus Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Q-Pharm Pty Ltd (Nucleus Network Pty Ltd)
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
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