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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05275465




Registration number
NCT05275465
Ethics application status
Date submitted
2/03/2022
Date registered
11/03/2022
Date last updated
7/04/2023

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
Scientific title
A Randomized, Placebo-controlled, Single-Ascending Dose Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
Secondary ID [1] 0 0
HH006-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HH-006
Treatment: Drugs - Placebo

Experimental: HH-006 -

Placebo Comparator: Placebo -


Treatment: Drugs: HH-006
Different dose levels of HH-006

Treatment: Drugs: Placebo
Different dose levels of placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment emergent adverse events (TEAEs)
Timepoint [1] 0 0
Day 1- Day 113
Primary outcome [2] 0 0
Severity of treatment emergent adverse events as measured by CTCAE v 5.0
Timepoint [2] 0 0
Day 1- Day 113
Primary outcome [3] 0 0
Duration of treatment emergent adverse events
Timepoint [3] 0 0
Day 1- Day 113
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
Day 1-Day 113
Secondary outcome [2] 0 0
Tmax
Timepoint [2] 0 0
Day 1-Day 113
Secondary outcome [3] 0 0
AUC0- last
Timepoint [3] 0 0
Day 1-Day 113
Secondary outcome [4] 0 0
AUC0-inf
Timepoint [4] 0 0
Day 1- Day 113
Secondary outcome [5] 0 0
t1/2
Timepoint [5] 0 0
Day 1- Day 113
Secondary outcome [6] 0 0
CL (SAD)
Timepoint [6] 0 0
Day 1-Day 113
Secondary outcome [7] 0 0
CL/F (SAD)
Timepoint [7] 0 0
Day 1-Day 113
Secondary outcome [8] 0 0
Vz/F (SAD)
Timepoint [8] 0 0
Day 1-Day 113
Secondary outcome [9] 0 0
Titres of anti drug antibodies (ADA) to HH-006
Timepoint [9] 0 0
Day 1- Day 113

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/12/2022
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd (Nucleus Network Pty Ltd) - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Huahui Health
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05275465
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries