Clinical trial NCT05275465: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B
Lead sponsor: Huahui Health
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment emergent adverse events (TEAEs)
timeFrame: Day 1- Day 113
measure: Severity of treatment emergent adverse events as measured by CTCAE v 5.0
timeFrame: Day 1- Day 113
measure: Duration of treatment emergent adverse events
timeFrame: Day 1- Day 113
Secondary outcomes:
measure: Cmax
timeFrame: Day 1-Day 113
measure: Tmax
timeFrame: Day 1-Day 113
measure: AUC0- last
timeFrame: Day 1-Day 113
measure: AUC0-inf
timeFrame: Day 1- Day 113
measure: t1/2
timeFrame: Day 1- Day 113
measure: CL (SAD)
timeFrame: Day 1-Day 113
measure: CL/F (SAD)
timeFrame: Day 1-Day 113
measure: Vz/F (SAD)
timeFrame: Day 1-Day 113
measure: Titres of anti drug antibodies (ADA) to HH-006
timeFrame: Day 1- Day 113
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Q-Pharm Pty Ltd (Nucleus Network Pty Ltd)
state: Queensland
Study officials:
affiliation: Nucleus Network
name: Jason Lickliter
role: PRINCIPAL_INVESTIGATOR
References: