Chronic Hepatitis BPhase 1NCT03714152
A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
A Phase 1 study testing ABI-H2158 in people with Chronic Hepatitis B, run by Assembly Biosciences at 14 sites in 7 countries.
Trial summary
This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ABI-H2158
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 14 sitesin 7 countries
- Study dates
- 13 Nov 2018to 7 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female ≥ 18 and ≤ 65 years of age.
- In good general health except for chronic HBV infection, documented by:
- Clinical history, physical exam and routine laboratory measurements without major or clinically significant findings
- Serologic profile consistent with chronic HBV infection • HBeAg-positive at Screening with HBV viral load ≥ 2× 105 IU/mL
- Liver evaluation demonstrating the absence of bridging fibrosis or cirrhosis
Who cannot join
- History or evidence of decompensated liver disease at any time prior to Screening
- History or presence of any other clinically significant current medical conditions requiring ongoing pharmacological treatment.
- Previous treatment with any investigational HBV antiviral treatments within the last 6 months, or previous treatment at any time with an investigational HBV antiviral treatment of the same class (core protein targeted therapies).
- Previous treatment with a commercially approved HBV therapy within the last 6 months
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
United States4 sites
Southern California Research Center
Coronado, California, 92118
Infectious Disease Care
Hillsborough, New Jersey, 08844
Research and Education
San Diego, California, 92115
Quest Clinical Research
San Francisco, California, 94115
Australia3 sites
Monash University
Clayton, Victoria
The Alfred Hospital
Melbourne, Victoria
Linear Clinical Research
Nedlands, Western Australia
South Korea3 sites
Hallym University
Chuncheon
Asan Medical Center
Seoul
Severance Hospital, Yonsei University
Seoul
About this study
Official title: A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single and Multiple Doses of ABI-H2158 in Healthy Volunteers; and the Multiple-Ascending Dose Pharmacokinetics and Pharmacodynamics in Patients With Chronic Hepatitis B Infection
This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.
- Conditions
- Chronic Hepatitis B
- Being tested
- ABI-H2158, Placebo for ABI-H2158
- Keywords
- CHB, HBV, hepatitis B, HBeAg positive
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-H2158Drug
5 mg or 25 mg tablets
Placebo for ABI-H2158Drug
Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| ABI-H2158 | Experimental | ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days Receives: Drug: ABI-H2158 |
| Matching Placebo for ABI-H2158 | Placebo comparator | Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days Receives: Drug: Placebo for ABI-H2158 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start13 Nov 2018
- Primary completion23 Nov 2020
- Study completion7 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714152
- Sponsor's protocol ID
- ABI-H2158-101
- Status last verified
- Jan 2021
- First submitted
- 17 Oct 2018
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single and Multiple Doses of ABI-H2158 in Healthy Volunteers; and the Multiple-Ascending Dose Pharmacokinetics and Pharmacodynamics in Patients With Chronic Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT03714152
- Acronym / sponsor ID
- ABI-H2158-101
- Conditions
- Chronic Hepatitis B
- Keywords
- CHB, HBV, hepatitis B, HBeAg positive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 22 Oct 2018 (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 three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABI-H2158 | Experimental | Drug: ABI-H2158ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days |
| Matching Placebo for ABI-H2158 | Placebo comparator | Drug: Placebo for ABI-H2158Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female ≥ 18 and ≤ 65 years of age.
- In good general health except for chronic HBV infection, documented by:
- Liver evaluation demonstrating the absence of bridging fibrosis or cirrhosis
Key exclusion criteria (4 listed)
- History or evidence of decompensated liver disease at any time prior to Screening
- History or presence of any other clinically significant current medical conditions requiring ongoing pharmacological treatment.
- Previous treatment with any investigational HBV antiviral treatments within the last 6 months, or previous treatment at any time with an investigational HBV antiviral treatment of the same class (core protein targeted therapies).
- Previous treatment with a commercially approved HBV therapy within the last 6 months
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-H21585 mg or 25 mg tablets | Drug | ABI-H2158 |
| Placebo for ABI-H2158Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets | Drug | Matching Placebo for ABI-H2158 |
Primary outcome
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: Up to 28 days
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: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABI-H2158 in people with Chronic Hepatitis B, run by Assembly Biosciences at 14 sites in 7 countries.
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 5 inclusion and 4 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 14 sites in United States, Australia, South Korea, China, Hong Kong and 2 more countries. 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 healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0. (time frame: Up to 28 days). 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.