Chronic Hepatitis B InfectionsPhase 1NCT07342868
Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
A Phase 1 study testing Pevifoscorvir Sodium (ALG-000184) in people with Chronic Hepatitis B Infections, run by Aligos Therapeutics at 1 site in United States.
Trial summary
This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment (Cohort 2), matched for age, body weight and, to the extent possible, for sex. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis B Infections
- What is being tested?
- Pevifoscorvir Sodium (ALG-000184)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to 19 Aug 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female between 18 and 75 years old
- BMI 17.5 to 40.0 kg/m^2 and a total body weight >50 kg (110 lb)
- Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non- sterile, male sexual partners agree to use highly effective contraceptive therapy
- Female subjects must have a negative serum pregnancy test at screening
- Inclusion Criteria for Subjects with Normal Hepatic Function:
- Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs and 12-lead electrocardiogram (ECG) assessment
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- Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, gender
- Normal hepatic function with no known or suspected hepatic impairment
- Inclusion Criteria for Subjects with Impaired Hepatic Function:
- Subject satisfies the criteria for Class B of the Child-Pugh classification (Child Pugh Scores 7-9 points) within 28 days of study drug administration
- A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, Fibroscan, computerized tomography scan, or magnetic resonance imaging (MRI)
- Stable hepatic impairment for at least 3 months prior to screening or second screening visit to demonstrate stability
- Stable concomitant medications for the management of an individual subject's medical history for at least 28 days prior to screening Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol criteria
Who cannot join
- Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
- Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
- Subjects with a history of clinically significant drug allergy
- Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use
- Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women and ≥21 units/week for men
- Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up
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- Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection. Subjects provided they met stable treatment criteria. Subjects with HIV infection may be eligible for moderate impairment cohort provided they met stable treatment criteria.
- Exclusion Criteria for Subjects with Normal Hepatic Function:
- Estimated creatinine clearance <60 mL/min/1.73 m2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula] - Unless otherwise instructed by the Study Review Committee (SRC), CKD-EPI should not be corrected for subjects of African ancestry
- Bilirubin (total, direct) >1.2× upper limit of normal (ULN) (unless Gilbert's is suspected)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 1.2×ULN
- Grade ≥1 Hemoglobin
- Exclusion Criteria for Subjects with Impaired Hepatic Function:
- Subjects with advanced ascites (Grade 3)
- Subjects with refractory encephalopathy as judged by the investigator.
- Subjects with esophageal variceal bleeding within the past 6 months prior to screening.
- Subjects with Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement.
- Estimated creatinine clearance <60 mL/min/1.73 m2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula] - Unless otherwise instructed by the SRC, CKD-EPI should not be corrected for subjects of African ancestry
- ALT or AST level ≥5×ULN
- Serum sodium ≤125 mmol/L
- Platelets <50×10^9/L
- Grade ≥2 Hemoglobin
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase 1 Non-Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety- and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment (Cohort 2), matched for age, body weight and, to the extent possible, for sex. The effect of hepatic impairment on the plasma pharmacokinetics of ALG-001075 will be assessed in subjects who have received single oral doses of pevifoscorvir sodium (ALG-000184).
- Conditions
- Chronic Hepatitis B Infections
- Being tested
- Pevifoscorvir Sodium (ALG-000184)
- Keywords
- Chronic Hepatitis B Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pevifoscorvir Sodium (ALG-000184)Drug
Pevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Hepatic Impairment | Experimental | Subjects with hepatic impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug. Receives: Drug: Pevifoscorvir Sodium (ALG-000184) |
| Subjects without Hepatic impairment | Experimental | Subjects without hepatic impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug. Receives: Drug: Pevifoscorvir Sodium (ALG-000184) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration time curve [AUC]
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Measured: Up to 4 days
Time to maximum plasma concentration [Tmax]
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Measured: Update to 4 Days
Maximum plasma concentration [Cmax]
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Measured: Update to 4 days
Minimum plasma concentration [Cmin]
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Measured: Up to 4 days
C0 (predose)
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Measured: Up to 4 days
Half-life [t1/2]
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Measured: Up to 4 Days
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start30 Jan 2026
- Primary completion19 Aug 2026
- Study completion19 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B InfectionsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment (Cohort 2), matched for age, body weight and, to the extent possible, for sex.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aligos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342868
- Sponsor's protocol ID
- ALG-000184-207
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2025
- Last updated
- 21 Aug 2026
- Results posted
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Non-Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety- and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT07342868
- Acronym / sponsor ID
- ALG-000184-207
- Conditions
- Chronic Hepatitis B Infections
- Keywords
- Chronic Hepatitis B Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aligos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 19 Aug 2026 (actual)
- Study completion
- 19 Aug 2026 (actual)
- First posted
- 15 Jan 2026 (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 Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment (Cohort 2), matched for age, body weight and, to the extent possible, for sex. The effect of hepatic impairment on the plasma pharmacokinetics of ALG-001075 will be assessed in subjects who have received single oral doses of pevifoscorvir sodium (ALG-000184).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment (Cohort 2), matched for age, body weight and, to the extent possible, for sex.
| Arm | Type | Receives |
|---|---|---|
| Subjects with Hepatic Impairment | Experimental | Drug: Pevifoscorvir Sodium (ALG-000184)Subjects with hepatic impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug. |
| Subjects without Hepatic impairment | Experimental | Drug: Pevifoscorvir Sodium (ALG-000184)Subjects without hepatic impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and Female between 18 and 75 years old
- BMI 17.5 to 40.0 kg/m^2 and a total body weight >50 kg (110 lb)
- Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non- sterile, male sexual partners agree to use highly effective contraceptive therapy
- Female subjects must have a negative serum pregnancy test at screening
- Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs and 12-lead electrocardiogram (ECG) assessment
Key exclusion criteria (22 listed)
- Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
- Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
- Subjects with a history of clinically significant drug allergy
- Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use
- Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women and ≥21 units/week for men
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 |
|---|---|---|
| Pevifoscorvir Sodium (ALG-000184)Pevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium | Drug | Subjects with Hepatic Impairment, Subjects without Hepatic impairment |
Primary outcome
Area under the concentration time curve [AUC]
Time frame: Up to 4 days
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Time to maximum plasma concentration [Tmax]
Time frame: Update to 4 Days
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Maximum plasma concentration [Cmax]
Time frame: Update to 4 days
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Minimum plasma concentration [Cmin]
Time frame: Up to 4 days
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
C0 (predose)
Time frame: Up to 4 days
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
Half-life [t1/2]
Time frame: Up to 4 Days
PK parameters of total ALG-001075 and the major metabolite ALG-000302 in plasma
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 15 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 21 Aug 2026.
- 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.
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 Pevifoscorvir Sodium (ALG-000184) in people with Chronic Hepatitis B Infections, run by Aligos Therapeutics at 1 site in United States.
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 13 inclusion and 22 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 21 Aug 2026. 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 United States. 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. 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?
Area under the concentration time curve [AUC] (time frame: Up to 4 days). The study lists 6 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 21 Aug 2026.