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

NCT05275465 | Completed Phase 1

• 1 other identifier: HH006-101
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Cmax

  Day 1-Day 113

• Tmax

  Day 1-Day 113

• AUC0- last

  Day 1-Day 113

• AUC0-inf

  Day 1- Day 113

• t1/2

  Day 1- Day 113

Study Arms (2)

HH-006

EXPERIMENTAL

Drug: HH-006

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HH-006 DRUG

Different dose levels of HH-006

HH-006

Placebo DRUG

Different dose levels of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huahui Health: lead

Study Sites (1)

Q-Pharm Pty Ltd (Nucleus Network Pty Ltd)

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Jason Lickliter

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: May 3, 2022
• Primary Completion: December 29, 2022
• Study Completion: December 29, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)