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Completed

NCT Number: NCT05275465

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Q-Pharm Pty Ltd (Nucleus Network Pty Ltd)

Brisbane, Queensland, 4006, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HH-006

Drug

Different dose levels of HH-006

Placebo

Drug

Different dose levels of placebo

Primary outcomes

  1. Number of participants with treatment emergent adverse events (TEAEs)

    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.

  2. Severity of treatment emergent adverse events as measured by CTCAE v 5.0

    Time frame: Day 1- Day 113

  3. Duration of treatment emergent adverse events

    Time frame: Day 1- Day 113

Secondary outcomes

  1. Cmax

    Time frame: Day 1-Day 113

    Maximum observed HH-006 concentration

  2. Tmax

    Time frame: Day 1-Day 113

    Time to maximum observed HH-006 concentration

  3. AUC0- last

    Time frame: Day 1-Day 113

    Area under the plasma concentration-time curve from time zero to the last time point with measurable concentration

  4. AUC0-inf

    Time frame: Day 1- Day 113

    AUC from time zero extrapolated to infinity

  5. t1/2

    Time frame: Day 1- Day 113

    Apparent terminal half-life

  6. CL (SAD)

    Time frame: Day 1-Day 113

    Apparent total body clearance

  7. CL/F (SAD)

    Time frame: Day 1-Day 113

    Apparent clearance

  8. Vz/F (SAD)

    Time frame: Day 1-Day 113

    Apparent terminal volume of distribution

  9. Titres of anti drug antibodies (ADA) to HH-006

    Time frame: Day 1- Day 113

    To determine the immunogenicity of HH-006

Sponsors and collaborators

Lead sponsor

Huahui Health

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2022
Registry last updated
Apr 7, 2023

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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