Chronic Hepatitis BPhase 1NCT05569941
A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects
A Phase 1 study testing ABI-4334 Tablet in people with Chronic Hepatitis B, run by Assembly Biosciences at 1 site in New Zealand.
Trial summary
This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects. Effect of food will also be evaluated in Part A. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ABI-4334 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteNew Zealand
- Study dates
- 11 Nov 2022to 12 Apr 2023
- 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
- Body mass index (BMI) between 18.0 and 30.0 kg/m2
- In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
- Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1
- Agreement to comply with protocol-specified contraceptive requirements
Who cannot join
- Positive results for any of the following serology tests, HBsAg, hepatitis B core antibody (HBcAb IgM), hepatitis C virus antibody (HCV Ab), or HIV-1 or -2 antibody
- History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or a condition known to interfere with the absorption/ distribution/elimination of drugs.
- History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, urticaria, or multiple drug allergies
- History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening
- Has participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months before Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Blinded, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics of Single and Multiple Ascending Doses of ABI-4334 in Healthy Subjects
This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects. Effect of food will also be evaluated in Part A.
- Conditions
- Chronic Hepatitis B
- Being tested
- ABI-4334 Tablet, ABI-4334 Placebo
- Keywords
- ABI-4334, PK, Healthy Subjects
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-4334 TabletDrug
ABI-4334 Tablet
ABI-4334 PlaceboDrug
Placebo to ABI-4334 Tablet
| Study group | Role | What they receive |
|---|---|---|
| Part A: SAD Cohorts 1-5 ABI-4334 Tablet | Experimental | A single dose of ABI-4334 will be administered on Day 1 in dose-escalation cohorts with a starting dose of 30 mg. The doses for subsequent cohorts will be determined by evaluation of safety and PK data from previous cohorts. Receives: Drug: ABI-4334 Tablet |
| Part A: SAD Cohorts 1-5 ABI-4334 Placebo Tablet | Placebo comparator | A single dose of placebo matching ABI-4334 will be administered on Day 1. Receives: Drug: ABI-4334 Placebo |
| Part A: SAD Fed Cohorts 6-7 ABI-4334 Tablet | Experimental | A single dose of ABI-4334 will be administered after a high-fat meal on Day 1 in cohort 6. A single dose of ABI-4334 will be administered on two separate occasions, once fasted and once after a high-fat meal in cohort 7. The dose administered will be determined after evaluation of cumulative safety and PK data from cohorts 1-5. Receives: Drug: ABI-4334 Tablet |
| Part A: SAD Fed Cohorts 6 ABI-4334 Placebo Tablet | Placebo comparator | A single dose of placebo matching ABI-4334 will be administered on Day 1 after a high-fat meal on Day 1 in cohort 6. Receives: Drug: ABI-4334 Placebo |
| Part B: MAD Cohorts 1-2 ABI-4334 Tablet | Experimental | Once-daily doses of ABI-4334 will be administered from Day 1 to Day 8. Cohort B1 will receive a dose determined from evaluation of the data from the SAD cohorts. The doses for the subsequent cohort will be determined by evaluation of safety and PK data from previous cohorts. Receives: Drug: ABI-4334 Tablet |
| Part B: MAD Cohorts 1-2 ABI-4334 Placebo Tablet | Placebo comparator | Once-daily doses of placebo matching ABI-4334 will be administered from Day 1 to Day 8. Receives: Drug: ABI-4334 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Measured: Up to Day 14
Secondary outcomes (14)
SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334
Measured: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Maximum Observed Plasma Concentration (Cmax) of ABI-4334
Measured: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334
Measured: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Apparent Terminal Elimination Half Life (t 1/2) of ABI-4334
Measured: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-4334
Measured: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-4334
Measured: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Comparison of Cmax between fasted and fed treatments of ABI-4334
Measured: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Comparison of AUC between fasted and fed treatments of ABI-4334
Measured: before and at pre-specified time points up to 144 hours after dosing
MAD Cohorts 1-2: AUC of ABI-4334
Measured: before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
MAD Cohorts 1-2: Cmax of ABI-4334
Measured: before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
MAD Cohorts 1-2: Tmax of ABI-4334
Measured: before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
MAD Cohorts 1-2: t 1/2 of ABI-4334
Measured: before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
MAD Cohorts 1-2: CL/F of ABI-4334
Measured: before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
MAD Cohorts 1-2: Vz/F of ABI-4334
Measured: before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start11 Nov 2022
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Gane, Principal investigator, New Zealand Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569941
- Sponsor's protocol ID
- ABI-4334-101
- Status last verified
- Sep 2023
- First submitted
- 3 Oct 2022
- Last updated
- 13 Sep 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Blinded, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics of Single and Multiple Ascending Doses of ABI-4334 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05569941
- Acronym / sponsor ID
- ABI-4334-101
- Conditions
- Chronic Hepatitis B
- Keywords
- ABI-4334, PK, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 6 Oct 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.
This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects. Effect of food will also be evaluated in Part A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: SAD Cohorts 1-5 ABI-4334 Tablet | Experimental | Drug: ABI-4334 TabletA single dose of ABI-4334 will be administered on Day 1 in dose-escalation cohorts with a starting dose of 30 mg. The doses for subsequent cohorts will be determined by evaluation of safety and PK data from previous cohorts. |
| Part A: SAD Cohorts 1-5 ABI-4334 Placebo Tablet | Placebo comparator | Drug: ABI-4334 PlaceboA single dose of placebo matching ABI-4334 will be administered on Day 1. |
| Part A: SAD Fed Cohorts 6-7 ABI-4334 Tablet | Experimental | Drug: ABI-4334 TabletA single dose of ABI-4334 will be administered after a high-fat meal on Day 1 in cohort 6. A single dose of ABI-4334 will be administered on two separate occasions, once fasted and once after a high-fat meal in cohort 7. The dose administered will be determined after evaluation of cumulative safety and PK data from cohorts 1-5. |
| Part A: SAD Fed Cohorts 6 ABI-4334 Placebo Tablet | Placebo comparator | Drug: ABI-4334 PlaceboA single dose of placebo matching ABI-4334 will be administered on Day 1 after a high-fat meal on Day 1 in cohort 6. |
| Part B: MAD Cohorts 1-2 ABI-4334 Tablet | Experimental | Drug: ABI-4334 TabletOnce-daily doses of ABI-4334 will be administered from Day 1 to Day 8. Cohort B1 will receive a dose determined from evaluation of the data from the SAD cohorts. The doses for the subsequent cohort will be determined by evaluation of safety and PK data from previous cohorts. |
| Part B: MAD Cohorts 1-2 ABI-4334 Placebo Tablet | Placebo comparator | Drug: ABI-4334 PlaceboOnce-daily doses of placebo matching ABI-4334 will be administered from Day 1 to Day 8. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) between 18.0 and 30.0 kg/m2
- In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
- Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1
- Agreement to comply with protocol-specified contraceptive requirements
Key exclusion criteria (5 listed)
- Positive results for any of the following serology tests, HBsAg, hepatitis B core antibody (HBcAb IgM), hepatitis C virus antibody (HCV Ab), or HIV-1 or -2 antibody
- History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or a condition known to interfere with the absorption/ distribution/elimination of drugs.
- History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, urticaria, or multiple drug allergies
- History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening
- Has participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months before Screening
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 |
|---|---|---|
| ABI-4334 TabletABI-4334 Tablet | Drug | Part A: SAD Cohorts 1-5 ABI-4334 Tablet, Part A: SAD Fed Cohorts 6-7 ABI-4334 Tablet, Part B: MAD Cohorts 1-2 ABI-4334 Tablet |
| ABI-4334 PlaceboPlacebo to ABI-4334 Tablet | Drug | Part A: SAD Cohorts 1-5 ABI-4334 Placebo Tablet, Part A: SAD Fed Cohorts 6 ABI-4334 Placebo Tablet, Part B: MAD Cohorts 1-2 ABI-4334 Placebo Tablet |
Primary outcome
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Time frame: Up to Day 14
14 secondary outcomes
SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334
Time frame: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Maximum Observed Plasma Concentration (Cmax) of ABI-4334
Time frame: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334
Time frame: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Apparent Terminal Elimination Half Life (t 1/2) of ABI-4334
Time frame: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-4334
Time frame: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-4334
Time frame: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Comparison of Cmax between fasted and fed treatments of ABI-4334
Time frame: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Comparison of AUC between fasted and fed treatments of ABI-4334
Time frame: before and at pre-specified time points up to 144 hours after dosing
MAD Cohorts 1-2: AUC of ABI-4334
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
MAD Cohorts 1-2: Cmax of ABI-4334
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
MAD Cohorts 1-2: Tmax of ABI-4334
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
MAD Cohorts 1-2: t 1/2 of ABI-4334
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
MAD Cohorts 1-2: CL/F of ABI-4334
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
MAD Cohorts 1-2: Vz/F of ABI-4334
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
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 13 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Edward Gane principal investigator
New Zealand Clinical Research
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 ABI-4334 Tablet in people with Chronic Hepatitis B, run by Assembly Biosciences at 1 site in New Zealand.
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 4 inclusion and 5 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 13 Sep 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 New Zealand. 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?
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results (time frame: Up to Day 14). 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 13 Sep 2023.