Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
Lead Sponsor:
Huahui Health
Conditions:
Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 v...
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
- 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
- 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.
Key Trial Info
Start Date :
May 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05275465
Start Date
May 3 2022
End Date
December 29 2022
Last Update
April 7 2023
Active Locations (1)
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1
Q-Pharm Pty Ltd (Nucleus Network Pty Ltd)
Brisbane, Queensland, Australia, 4006