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

Phase 1

Completed

• Conditions: Hepatitis B
• Interventions: Drug: HH-006; Drug: Placebo

• Registration Number: NCT05275465
• Lead Sponsor: Huahui Health

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.

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-11
• Study Start: 2022-05-03
• Primary Completion: 2022-12-29
• Study Completion: 2022-12-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HH-006	HH-006	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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
Number of participants with treatment emergent adverse events (TEAEs)	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.

Secondary Outcome Measures

Name	Time	Method
t1/2	Day 1- Day 113	Apparent terminal half-life
Tmax	Day 1-Day 113	Time to maximum observed HH-006 concentration
Cmax	Day 1-Day 113	Maximum observed HH-006 concentration
AUC0-inf	Day 1- Day 113	AUC from time zero extrapolated to infinity
Vz/F (SAD)	Day 1-Day 113	Apparent terminal volume of distribution
Titres of anti drug antibodies (ADA) to HH-006	Day 1- Day 113	To determine the immunogenicity of HH-006
CL (SAD)	Day 1-Day 113	Apparent total body clearance
AUC0- last	Day 1-Day 113	Area under the plasma concentration-time curve from time zero to the last time point with measurable concentration
CL/F (SAD)	Day 1-Day 113	Apparent clearance

Trial Locations

Locations (1)

Q-Pharm Pty Ltd (Nucleus Network Pty Ltd); 🇦🇺 Brisbane, Queensland, Australia