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

A Randomized, Placebo-controlled, Single-Ascending Dose Phase Ia 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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Drug: HH-006; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mu Yang; Phone Number: +86138-2130-8821; Email: yangmu@hhhbio.com
• Study Contact Backup: Name: Chen Xueyan; Phone Number: +86 18363850115; Email: chenxueyan@hhhbio.com

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • Q-Pharm Pty Ltd (Nucleus Network Pty Ltd)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Different dose levels of placebo
Experimental: HH-006	Drug: HH-006; Different dose levels of HH-006

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Huahui Health

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Actual): December 29, 2022
• Study Completion (Actual): December 29, 2022

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis; Hepatitis B
• Other Study ID Numbers: HH006-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No