search
Back to results

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
Huahui Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
March 2, 2022
Last Updated
April 6, 2023
Sponsor
Huahui Health
search

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

We'll reach out to this number within 24 hrs