Chronic Hepatitis B Virus InfectionPhase 1NCT04971512
A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.
A Phase 1 study testing EDP-721, EDP-721 (Part 2) and EDP-514 in people with Chronic Hepatitis B Virus Infection, run by Enanta Pharmaceuticals, Inc at 1 site in New Zealand.
Trial summary
Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EDP-721 in healthy subjects. 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 Virus Infection
- What is being tested?
- EDP-721, EDP-721 (Part 2) and EDP-514
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteNew Zealand
- Study dates
- 2 Aug 2021to 20 Dec 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
- An informed consent document signed and dated by the subject.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.
- An informed consent document signed and dated by the subject.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive
- HBsAg detectable in serum/plasma at Screening and in the most recent HBsAg serum/plasma testing at least 6 months previously.
- HBV DNA levels:
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- A Screening HBV DNA level in serum/plasma that is <LLOQ and
- No HBV DNA serum/plasma test values ≥LLOQ over the previous 12 months (using an approved test)
- CHB subjects must have been on their prescribed HBV NUC treatment with no change in regimen for 12 months prior to Screening
- An informed consent document signed and dated by the subject.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive
- HBsAg detectable in serum/plasma at Screening and in the most recent HBsAg serum/plasma testing at least 6 months previously.
- HBV DNA levels:
- For subjects who are HBeAg positive at Screening, a Screening HBV DNA level in serum/plasma that is ≥20,000 IU/ml, or
- For subjects who are HBeAg negative at Screening, a Screening HBV DNA level in serum/plasma that is ≥2,000 IU/mL, and
- For all subjects, no HBV DNA serum/plasma test values <1,000 IU/ml over the previous 12 months (using an approved test)
- CHB subjects must not have been on prescribed anti-HBV treatment, specifically pegIFN and/or NUC therapy for at least 12 months prior to Screening
- Exclusion Criteria (Nuc-Suppressed and Viremic CHB Population):
- A documented prior diagnosis of cirrhosis
- Pregnant or nursing females
- Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV
- Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases
Who cannot join
- Clinically relevant evidence or history of illness or disease.
- Pregnant or nursing females.
- History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- A positive urine drug screen at screening or Day -1.
- Current tobacco smokers or use of tobacco within 3 months prior to screening.
- Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
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- History of regular alcohol consumption.
- Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.
- Part 2 (CHB Population)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP-721 in Healthy Subjects (Part 1) and the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of EDP-721 in Combination With EDP-514 in Patients With Chronic Hepatitis B Virus Infection (Part 2)
Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EDP-721 in healthy subjects.
Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of EDP-721 in combination with EDP-514 in patients with chronic hepatitis B virus infection.
- Conditions
- Chronic Hepatitis B Virus Infection
- Being tested
- EDP-721, Placebo (Part 1), EDP-721 (Part 2), Placebo (Part 2), EDP-514
- Keywords
- First-in-Human, Single Ascending Dose, Multiple Ascending Dose, Hepatitis B virus, HBV
- 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.
EDP-721Drug
Oral administration (Part 1)
Placebo (Part 1)Drug
Placebo to match EDP-721, oral administration (Part 1)
EDP-721 (Part 2)Drug
Oral administration (Part 2)
Placebo (Part 2)Drug
Placebo to match EDP-721 (Part 2)
EDP-514Drug
Oral administration
Placebo (Part 2)Drug
Placebo to match EDP-514
| Study group | Role | What they receive |
|---|---|---|
| EDP-721 HV SAD Cohorts | Experimental | EDP-721 Dose 1, Dose 2, Dose 3 and Dose 4, in one single administration Receives: Drug: EDP-721 |
| EDP-721 HV MAD Cohorts | Experimental | EDP-721 Dose 1, Dose 2 and Dose 3, once daily for 14 days Receives: Drug: EDP-721 |
| EDP-721 HV SAD Placebo Cohort | Placebo comparator | Matching placebo, in one single administration Receives: Drug: Placebo (Part 1) |
| EDP-721 HV MAD Placebo Cohort | Placebo comparator | Matching placebo, once daily for 14 days Receives: Drug: Placebo (Part 1) |
| EDP-721+ EDP-514 HBV MAD Cohorts | Experimental | EDP-721 once daily for 14 days followed by EDP-721+EDP-514 once daily for 28 days Receives: Drug: EDP-721 (Part 2); Drug: EDP-514 |
| EDP-721+ EDP-514 HBV MAD Placebo Cohorts | Placebo comparator | Matching placebo once daily for 42 days Receives: Drug: Placebo (Part 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by adverse events
Measured: Up to 8 Days in HV SAD Cohorts
Safety measured by adverse events
Measured: Up to 21 Days in HV MAD Cohorts
Safety measured by adverse events
Measured: Up to 70 Days in NUC-suppressed CHB MAD Cohorts
Safety measured by adverse events
Measured: Up to 98 Days in Viremic CHB MAD Cohorts
Secondary outcomes (10)
Cmax of EDP-721
Measured: Up to 6 Days in HV SAD Cohorts
AUC of EDP-721
Measured: Up to 6 Days in HV SAD Cohorts
Cmax of EDP-721
Measured: Up to 18 Days in HV MAD Cohorts
AUC of EDP-721
Measured: Up to 18 Days in HV MAD Cohorts
Cmax of EDP-721 alone and in combination with EDP-514
Measured: Up to 28 Days in All CHB MAD Cohorts
AUC of EDP-721 alone and in combination with EDP-514
Measured: Up to 28 Days in All CHB MAD Cohorts
Cmax of EDP-514 in combination with EDP-721
Measured: Up to 28 Days in All CHB MAD Cohorts
AUC of EDP-514 in combination with EDP-721
Measured: Up to 28 Days in All CHB MAD Cohorts
Change from baseline in HBV DNA Viral Load Assay
Measured: Through Day 28 in All CHB MAD Cohorts
Change from baseline in quantitative HBsAg
Measured: Through Day 28 in All CHB MAD Cohorts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start2 Aug 2021
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Why it stopped: Due to adverse safety signals in Part 1 (HV)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B Virus InfectionStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971512
- Sponsor's protocol ID
- EDP 721-001
- Status last verified
- Feb 2022
- First submitted
- 12 Jul 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP-721 in Healthy Subjects (Part 1) and the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of EDP-721 in Combination With EDP-514 in Patients With Chronic Hepatitis B Virus Infection (Part 2)
- ClinicalTrials.gov ID
- NCT04971512
- Acronym / sponsor ID
- EDP 721-001
- Conditions
- Chronic Hepatitis B Virus Infection
- Keywords
- First-in-Human, Single Ascending Dose, Multiple Ascending Dose, Hepatitis B virus, HBV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to adverse safety signals in Part 1 (HV)
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 21 Jul 2021 (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.
Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EDP-721 in healthy subjects.
Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of EDP-721 in combination with EDP-514 in patients with chronic hepatitis B virus infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| EDP-721 HV SAD Cohorts | Experimental | Drug: EDP-721EDP-721 Dose 1, Dose 2, Dose 3 and Dose 4, in one single administration |
| EDP-721 HV MAD Cohorts | Experimental | Drug: EDP-721EDP-721 Dose 1, Dose 2 and Dose 3, once daily for 14 days |
| EDP-721 HV SAD Placebo Cohort | Placebo comparator | Drug: Placebo (Part 1)Matching placebo, in one single administration |
| EDP-721 HV MAD Placebo Cohort | Placebo comparator | Drug: Placebo (Part 1)Matching placebo, once daily for 14 days |
| EDP-721+ EDP-514 HBV MAD Cohorts | Experimental | Drug: EDP-721 (Part 2), Drug: EDP-514EDP-721 once daily for 14 days followed by EDP-721+EDP-514 once daily for 28 days |
| EDP-721+ EDP-514 HBV MAD Placebo Cohorts | Placebo comparator | Drug: Placebo (Part 2)Matching placebo once daily for 42 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- An informed consent document signed and dated by the subject.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.
- An informed consent document signed and dated by the subject.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive
- HBsAg detectable in serum/plasma at Screening and in the most recent HBsAg serum/plasma testing at least 6 months previously.
Key exclusion criteria (9 listed)
- Clinically relevant evidence or history of illness or disease.
- Pregnant or nursing females.
- History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- A positive urine drug screen at screening or Day -1.
- Current tobacco smokers or use of tobacco within 3 months prior to 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 |
|---|---|---|
| EDP-721Oral administration (Part 1) | Drug | EDP-721 HV MAD Cohorts, EDP-721 HV SAD Cohorts |
| Placebo (Part 1)Placebo to match EDP-721, oral administration (Part 1) | Drug | EDP-721 HV MAD Placebo Cohort, EDP-721 HV SAD Placebo Cohort |
| EDP-721 (Part 2)Oral administration (Part 2) | Drug | EDP-721+ EDP-514 HBV MAD Cohorts |
| Placebo (Part 2)Placebo to match EDP-721 (Part 2) | Drug | EDP-721+ EDP-514 HBV MAD Placebo Cohorts |
| EDP-514Oral administration | Drug | EDP-721+ EDP-514 HBV MAD Cohorts |
| Placebo (Part 2)Placebo to match EDP-514 | Drug | EDP-721+ EDP-514 HBV MAD Placebo Cohorts |
Primary outcome
Safety measured by adverse events
Time frame: Up to 8 Days in HV SAD Cohorts
Safety measured by adverse events
Time frame: Up to 21 Days in HV MAD Cohorts
Safety measured by adverse events
Time frame: Up to 70 Days in NUC-suppressed CHB MAD Cohorts
Safety measured by adverse events
Time frame: Up to 98 Days in Viremic CHB MAD Cohorts
10 secondary outcomes
Cmax of EDP-721
Time frame: Up to 6 Days in HV SAD Cohorts
AUC of EDP-721
Time frame: Up to 6 Days in HV SAD Cohorts
Cmax of EDP-721
Time frame: Up to 18 Days in HV MAD Cohorts
AUC of EDP-721
Time frame: Up to 18 Days in HV MAD Cohorts
Cmax of EDP-721 alone and in combination with EDP-514
Time frame: Up to 28 Days in All CHB MAD Cohorts
AUC of EDP-721 alone and in combination with EDP-514
Time frame: Up to 28 Days in All CHB MAD Cohorts
Cmax of EDP-514 in combination with EDP-721
Time frame: Up to 28 Days in All CHB MAD Cohorts
AUC of EDP-514 in combination with EDP-721
Time frame: Up to 28 Days in All CHB MAD Cohorts
Change from baseline in HBV DNA Viral Load Assay
Time frame: Through Day 28 in All CHB MAD Cohorts
Change from baseline in quantitative HBsAg
Time frame: Through Day 28 in All CHB MAD Cohorts
Results and safety
The study was stopped early (reason given: Due to adverse safety signals in Part 1 (HV)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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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.
Enanta Pharmaceuticals, Inc study director
Enanta Pharmaceuticals, Inc
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 EDP-721, EDP-721 (Part 2) and EDP-514 in people with Chronic Hepatitis B Virus Infection, run by Enanta Pharmaceuticals, Inc 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 22 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Feb 2022. 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 was stopped early (reason given: Due to adverse safety signals in Part 1 (HV)). Results are not available in the source record.
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?
Safety measured by adverse events (time frame: Up to 8 Days in HV SAD Cohorts). The study lists 4 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 14 Feb 2022.