Chronic Hepatitis BPhase 1NCT04271592
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults
A Phase 1 study testing ABI-H3733 Liquid Oral Dosage Form and ABI-H3733 Solid Oral Dosage Form 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, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1 includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending dose (SAD) and multiple-ascending dose (MAD)… 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-H3733 Liquid Oral Dosage Form and ABI-H3733 Solid Oral Dosage Form
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteNew Zealand
- Study dates
- 17 May 2020to 14 Jan 2021
- 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
- No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.
Who cannot join
- Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
- History of or current persistent drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose Escalation and Food Effect Study of ABI-H3733 in Healthy Subjects
This study is designed to assess safety, tolerability, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1 includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending dose (SAD) and multiple-ascending dose (MAD) administration of the oral liquid formulation. Part 2 includes assessment of a solid dosage formulation of ABI-H3733 in participants under fasted conditions or after a high-fat meal. Optional cohorts may be enrolled in Parts 1 and 2 of the study to explore additional dose levels, solid oral dosage formulations, or for cohort expansion.
- Conditions
- Chronic Hepatitis B
- Being tested
- ABI-H3733 Liquid Oral Dosage Form, ABI-H3733 Solid Oral Dosage Form, Placebo to ABI-H3733 Liquid Oral Dosage Form, Placebo to ABI-H3733 Solid Oral Dosage Form
- 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-H3733 Liquid Oral Dosage FormDrug
ABI-H3733 liquid oral dosage form
ABI-H3733 Solid Oral Dosage FormDrug
ABI-H3733 solid oral dosage form
Placebo to ABI-H3733 Liquid Oral Dosage FormDrug
Placebo to ABI-H3733 liquid oral dosage form
Placebo to ABI-H3733 Solid Oral Dosage FormDrug
Placebo to ABI-H3733 solid oral dosage form
| Study group | Role | What they receive |
|---|---|---|
| Part 1: SAD Cohorts 1-7 ABI-H3733 Liquid Form | Experimental | A single dose of ABI-H3733 liquid oral dosage form administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. Receives: Drug: ABI-H3733 Liquid Oral Dosage Form |
| Part 1: SAD Cohorts 1-7 Placebo Liquid Form | Placebo comparator | A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. Receives: Drug: Placebo to ABI-H3733 Liquid Oral Dosage Form |
| Part 1: MAD Cohorts 8-10 ABI-H3733 Liquid Form | Experimental | Once-daily doses of ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. Receives: Drug: ABI-H3733 Liquid Oral Dosage Form |
| Part 1: MAD Cohorts 8-10 Placebo Liquid Form | Placebo comparator | Once-daily doses of placebo matching ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. Receives: Drug: Placebo to ABI-H3733 Liquid Oral Dosage Form |
| Part 2: Single Dose Fasted Cohort 11 ABI-H3733 Solid Form | Experimental | A single dose of ABI-H3733 solid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. Receives: Drug: ABI-H3733 Solid Oral Dosage Form |
| Part 2: Single Dose Fasted Cohort 11 Placebo Solid Form | Placebo comparator | A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. Receives: Drug: Placebo to ABI-H3733 Solid Oral Dosage Form |
| Part 2: Single Dose Fed Cohort 12 ABI-H3733 Solid Form | Experimental | A single dose of ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. Receives: Drug: ABI-H3733 Solid Oral Dosage Form |
| Part 2: Single Dose Fed Cohort 12 Placebo Solid Form | Placebo comparator | A single dose of placebo matching ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. Receives: Drug: Placebo to ABI-H3733 Solid Oral Dosage Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Adverse Events
Measured: Up to Day 10
Number of Participants with One or More Related Adverse Events
Measured: Up to Day 10
Number of Participants with One or More Severe (Grade ≥3) Adverse Events
Measured: Up to Day 10
Secondary outcomes (14)
SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-H3733
Measured: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Maximum Plasma Concentration (Cmax) ABI-H3733
Measured: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Time of Cmax (Tmax) of ABI-H3733
Measured: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Apparent Terminal Elimination Half-life (t1/2) of ABI-H3733
Measured: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-H3733
Measured: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-H3733
Measured: before and at pre-specified time points up to 120 hours after dosing
MAD Cohorts 8-10: AUC of ABI-H3733
Measured: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
MAD Cohorts 8-10: Cmax Over the Dosing Interval of ABI-H3733
Measured: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
MAD Cohorts 8-10: Tmax of ABI-H3733
Measured: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
MAD Cohorts 8-10: t1/2 of ABI-H3733
Measured: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
Single Dose Cohorts 11-12: AUC of ABI-H3733
Measured: before and at pre-specified time points up to 120 hours after dosing
Single Dose Cohorts 11-12: Cmax of ABI-H3733
Measured: before and at pre-specified time points up to 120 hours after dosing
Single Dose Cohorts 11-12: Tmax of ABI-H3733
Measured: before and at pre-specified time points up to 120 hours after dosing
Single Dose Cohorts 11-12: t1/2 of ABI-H3733
Measured: before and at pre-specified time points up to 120 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start17 May 2020
- Primary completion3 Nov 2020
- Study completion14 Jan 2021
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katia Alves, MD, Study director, Assembly Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271592
- Sponsor's protocol ID
- ABI-H3733-101
- Other IDs
- U1111-1246-2965
- Status last verified
- Jan 2021
- First submitted
- 13 Feb 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose Escalation and Food Effect Study of ABI-H3733 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04271592
- Acronym / sponsor ID
- ABI-H3733-101
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 17 May 2020 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 17 Feb 2020 (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, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1 includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending dose (SAD) and multiple-ascending dose (MAD) administration of the oral liquid formulation. Part 2 includes assessment of a solid dosage formulation of ABI-H3733 in participants under fasted conditions or after a high-fat meal. Optional cohorts may be enrolled in Parts 1 and 2 of the study to explore additional dose levels, solid oral dosage formulations, or for cohort expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: SAD Cohorts 1-7 ABI-H3733 Liquid Form | Experimental | Drug: ABI-H3733 Liquid Oral Dosage FormA single dose of ABI-H3733 liquid oral dosage form administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 1: SAD Cohorts 1-7 Placebo Liquid Form | Placebo comparator | Drug: Placebo to ABI-H3733 Liquid Oral Dosage FormA single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 1: MAD Cohorts 8-10 ABI-H3733 Liquid Form | Experimental | Drug: ABI-H3733 Liquid Oral Dosage FormOnce-daily doses of ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 1: MAD Cohorts 8-10 Placebo Liquid Form | Placebo comparator | Drug: Placebo to ABI-H3733 Liquid Oral Dosage FormOnce-daily doses of placebo matching ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 2: Single Dose Fasted Cohort 11 ABI-H3733 Solid Form | Experimental | Drug: ABI-H3733 Solid Oral Dosage FormA single dose of ABI-H3733 solid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Part 2: Single Dose Fasted Cohort 11 Placebo Solid Form | Placebo comparator | Drug: Placebo to ABI-H3733 Solid Oral Dosage FormA single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Part 2: Single Dose Fed Cohort 12 ABI-H3733 Solid Form | Experimental | Drug: ABI-H3733 Solid Oral Dosage FormA single dose of ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Part 2: Single Dose Fed Cohort 12 Placebo Solid Form | Placebo comparator | Drug: Placebo to ABI-H3733 Solid Oral Dosage FormA single dose of placebo matching ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.
Key exclusion criteria (2 listed)
- Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
- History of or current persistent drug or alcohol abuse.
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-H3733 Liquid Oral Dosage FormABI-H3733 liquid oral dosage form | Drug | Part 1: MAD Cohorts 8-10 ABI-H3733 Liquid Form, Part 1: SAD Cohorts 1-7 ABI-H3733 Liquid Form |
| ABI-H3733 Solid Oral Dosage FormABI-H3733 solid oral dosage form | Drug | Part 2: Single Dose Fasted Cohort 11 ABI-H3733 Solid Form, Part 2: Single Dose Fed Cohort 12 ABI-H3733 Solid Form |
| Placebo to ABI-H3733 Liquid Oral Dosage FormPlacebo to ABI-H3733 liquid oral dosage form | Drug | Part 1: MAD Cohorts 8-10 Placebo Liquid Form, Part 1: SAD Cohorts 1-7 Placebo Liquid Form |
| Placebo to ABI-H3733 Solid Oral Dosage FormPlacebo to ABI-H3733 solid oral dosage form | Drug | Part 2: Single Dose Fasted Cohort 11 Placebo Solid Form, Part 2: Single Dose Fed Cohort 12 Placebo Solid Form |
Primary outcome
Number of Participants with One or More Adverse Events
Time frame: Up to Day 10
Number of Participants with One or More Related Adverse Events
Time frame: Up to Day 10
Number of Participants with One or More Severe (Grade ≥3) Adverse Events
Time frame: Up to Day 10
14 secondary outcomes
SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Maximum Plasma Concentration (Cmax) ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Time of Cmax (Tmax) of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Apparent Terminal Elimination Half-life (t1/2) of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
MAD Cohorts 8-10: AUC of ABI-H3733
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
MAD Cohorts 8-10: Cmax Over the Dosing Interval of ABI-H3733
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
MAD Cohorts 8-10: Tmax of ABI-H3733
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
MAD Cohorts 8-10: t1/2 of ABI-H3733
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
Single Dose Cohorts 11-12: AUC of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
Single Dose Cohorts 11-12: Cmax of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
Single Dose Cohorts 11-12: Tmax of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
Single Dose Cohorts 11-12: t1/2 of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
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 27 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
Katia Alves, MD study director
Assembly Biosciences
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-H3733 Liquid Oral Dosage Form and ABI-H3733 Solid Oral Dosage Form 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 1 inclusion and 2 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 27 Jan 2021. 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?
Number of Participants with One or More Adverse Events (time frame: Up to Day 10). 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 27 Jan 2021.