Hepatitis BPhase 1NCT05275465
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
A Phase 1 study testing HH-006 in people with Hepatitis B, run by Huahui Health at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- HH-006
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteAustralia
- Study dates
- 3 May 2022to 29 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Q-Pharm Pty Ltd (Nucleus Network Pty Ltd)
Brisbane, Queensland, 4006
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis B
- Being tested
- HH-006, Placebo
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HH-006Drug
Different dose levels of HH-006
PlaceboDrug
Different dose levels of placebo
| Study group | Role | What they receive |
|---|---|---|
| HH-006 | Experimental | Not described Receives: Drug: HH-006 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1- Day 113
Severity of treatment emergent adverse events as measured by CTCAE v 5.0
Measured: Day 1- Day 113
Duration of treatment emergent adverse events
Measured: Day 1- Day 113
Secondary outcomes (9)
Cmax
Maximum observed HH-006 concentration
Measured: Day 1-Day 113
Tmax
Time to maximum observed HH-006 concentration
Measured: Day 1-Day 113
AUC0- last
Area under the plasma concentration-time curve from time zero to the last time point with measurable concentration
Measured: Day 1-Day 113
AUC0-inf
AUC from time zero extrapolated to infinity
Measured: Day 1- Day 113
t1/2
Apparent terminal half-life
Measured: Day 1- Day 113
CL (SAD)
Apparent total body clearance
Measured: Day 1-Day 113
CL/F (SAD)
Apparent clearance
Measured: Day 1-Day 113
Vz/F (SAD)
Apparent terminal volume of distribution
Measured: Day 1-Day 113
Titres of anti drug antibodies (ADA) to HH-006
To determine the immunogenicity of HH-006
Measured: Day 1- Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start3 May 2022
- Primary completion29 Dec 2022
- Study completion29 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huahui Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Lickliter, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275465
- Sponsor's protocol ID
- HH006-101
- Status last verified
- Apr 2023
- First submitted
- 2 Mar 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05275465
- Acronym / sponsor ID
- HH006-101
- Conditions
- Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Huahui HealthIndustry (pharma, biotech, devices)
- Study start
- 3 May 2022 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 29 Dec 2022 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HH-006 | Experimental | Drug: HH-006 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HH-006Different dose levels of HH-006 | Drug | HH-006 |
| PlaceboDifferent dose levels of placebo | Drug | Placebo |
Primary outcome
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: Day 1- Day 113
An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.
Severity of treatment emergent adverse events as measured by CTCAE v 5.0
Time frame: Day 1- Day 113
Duration of treatment emergent adverse events
Time frame: Day 1- Day 113
9 secondary outcomes
Cmax
Time frame: Day 1-Day 113
Tmax
Time frame: Day 1-Day 113
AUC0- last
Time frame: Day 1-Day 113
AUC0-inf
Time frame: Day 1- Day 113
t1/2
Time frame: Day 1- Day 113
CL (SAD)
Time frame: Day 1-Day 113
CL/F (SAD)
Time frame: Day 1-Day 113
Vz/F (SAD)
Time frame: Day 1-Day 113
Titres of anti drug antibodies (ADA) to HH-006
Time frame: Day 1- Day 113
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Hepatitis B
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Lickliter principal investigator
Nucleus Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HH-006 in people with Hepatitis B, run by Huahui Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment emergent adverse events (TEAEs) (time frame: Day 1- Day 113). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.