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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-03

Study Completion Date

2022-12-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HH-006

Group Type EXPERIMENTAL

HH-006

Intervention Type DRUG

Different dose levels of HH-006

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Different dose levels of placebo

Interventions

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HH-006

Different dose levels of HH-006

Intervention Type DRUG

Placebo

Different dose levels of placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes