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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05275465
• Other study ID #: HH006-101
• Status: Completed
• Phase: Phase 1
• Start date: May 3, 2022
• Est. completion date: December 29, 2022

Study information

• Verified date: April 2023
• Source: Huahui Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 29, 2022
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Drug:
• HH-006
Different dose levels of HH-006
• Placebo
Different dose levels of placebo

Locations

Country	Name	City	State
Australia	Q-Pharm Pty Ltd (Nucleus Network Pty Ltd)	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Huahui Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Severity of treatment emergent adverse events as measured by CTCAE v 5.0		Day 1- Day 113
Primary	Duration of treatment emergent adverse events		Day 1- Day 113
Secondary	Cmax	Maximum observed HH-006 concentration	Day 1-Day 113
Secondary	Tmax	Time to maximum observed HH-006 concentration	Day 1-Day 113
Secondary	AUC0- last	Area under the plasma concentration-time curve from time zero to the last time point with measurable concentration	Day 1-Day 113
Secondary	AUC0-inf	AUC from time zero extrapolated to infinity	Day 1- Day 113
Secondary	t1/2	Apparent terminal half-life	Day 1- Day 113
Secondary	CL (SAD)	Apparent total body clearance	Day 1-Day 113
Secondary	CL/F (SAD)	Apparent clearance	Day 1-Day 113
Secondary	Vz/F (SAD)	Apparent terminal volume of distribution	Day 1-Day 113
Secondary	Titres of anti drug antibodies (ADA) to HH-006	To determine the immunogenicity of HH-006	Day 1- Day 113