Chronic Hepatitis BPhase 1NCT04536337
A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
A Phase 1 study testing ALG-000184 and Entecavir in people with Chronic Hepatitis B, run by Aligos Therapeutics at 10 sites in 6 countries.
Trial summary
The goal of this clinical trial is to learn if ALG-000184 is safe, well-tolerated, and works to treat chronic hepatitis B virus (HBV) infection. The main questions it aims to answer are: Is ALG-000184 safe and well-tolerated when given alone or with entecavir (a standard HBV treatment)? Does ALG-000184 reduce HBV… 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?
- ALG-000184 and Entecavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 22 Oct 2020to 16 Jun 2025
- 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
- Female subjects must have a negative serum pregnancy test at screening
- Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria
- In addition to inclusion criteria 1-2, the following inclusion criteria also apply to HV's (Parts 1 and 2)
- Male or female between 18 and 55 years of age, extremes included.
- Subjects must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 32.0 kg/m2, extremes included.
- CHB Subjects:
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- In addition to inclusion criteria 1-4, the following inclusion criteria also apply to CHB subjects:
- All of the Following criteria apply to Part 3 at screening:
- 5 .Subjects must be 18 to 65 years of age, extremes included.
- 6.CHB subjects must have a BMI of 18.0 to 35.0 kg/m2, extremes included.
- 7.CHB subjects who at screening, have not received treatment with an approved or investigational medicine, or have never received treatment with HBV antiviral medicines
- All of the following criteria apply to Part 4 Cohorts A \& B, unless otherwise specified, at Screening:
- 8.Subjects must be 18 to 65 years of age, extremes included.
- 9.Subjects must have a BMI of 18.0 to 35.0 kg/m2, extremes included
- 10.Subjects must be HBeAg positive (HBeAg ≥LLOQ and HBeAb negative)
- 11.Subjects enrolled in Part 4 Cohort A and B must have a history of Chronic Hepatitis B
- 12. Subjects must have ALT and AST must have ≤1.2×ULN or ≤5×ULN
- All of the following criteria apply to Part 5 at Screening
- 13.Subjects must be 18 to 65 years of age, extremes included.
- 14. Subjects have a BMI of 17.0 to 35.0 kg/m2, extremes included
- 15.Subjects could belong to any of the following treatment categories: treatment naïve (TN), currently not treated (CNT) , virologically suppressed.
Who cannot join
- Subjects with any previous or current 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 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 of clinical evidence at screening of significant or unstable cardiac disease etc.
- Subjects with a history of clinically significant drug allergy
- Subject with a current history of clinically significant (as determined by investigator) skin disease requiring intermittent or chronic treatment
- Excessive use of alcohol, defined as regular consumption of ≥14 standard drinks/week for women and ≥21 standard drinks/week for men
- Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
Show all 17Show fewer
- In addition to exclusion criteria 1-6, the following exclusion criteria also apply to HV's (Parts 1 and 2)
- Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow up.
- Positive alcohol or cotinine test at screening and Day -1.
- Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m2at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula).
- All exclusion criteria listed above for healthy volunteers apply also to CHB subjects, except for exclusion Criteria 9 (requirement relative to cotinine).All the following exclusion criteria apply to Parts 3, 4, and 5, unless otherwise specified.
- Subjects who are positive for anti-HBs antibodies.
- For HBeAg-positive subjects, they should be negative for anti-HBe antibodies (Parts 4 and 5)
- Subject with any history or current evidence of hepatic decompensation such as: variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy, or active jaundice (within the last year).
- History or current evidence of cirrhosis.
- Subjects with liver fibrosis that is classified as Metavir Score ≥F3 liver disease
- Subjects with signs of hepatocellular carcinoma
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
China3 sites
The First Hospital of Jilin University
Changchun, Jilin, 130021
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong
Australia2 sites
Saint Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Western Health
Footscray, Victoria, 3011
Moldova1 site
PMSI Republican Clinical Hospital "T. Mosneaga", ARENSIA Exploratory Medicine Phase I Unit
Chisinau
About this study
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Orally Administered ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single-Ascending Doses (Part 1) and Multiple-Ascending Doses in Healthy Volunteers (Part 2), and Multiple Doses in Subjects With Chronic Hepatitis B (Part 3)
The goal of this clinical trial is to learn if ALG-000184 is safe, well-tolerated, and works to treat chronic hepatitis B virus (HBV) infection. The main questions it aims to answer are:
Is ALG-000184 safe and well-tolerated when given alone or with entecavir (a standard HBV treatment)? Does ALG-000184 reduce HBV viral levels in the blood of patients with chronic hepatitis B? How does the body process ALG-000184 (pharmacokinetics)?
Read more
Researchers will compare ALG-000184 to placebo (a look-alike substance that contains no drug) to see if ALG-000184 works better at reducing hepatitis B viral markers.
The study has five parts:
Parts 1 and 2: Healthy volunteers will receive single or multiple doses of ALG-000184 or placebo Part 3: Patients with chronic hepatitis B will receive ALG-000184 or placebo daily for 28 days Part 4: Patients with chronic hepatitis B will receive ALG-000184 or placebo combined with entecavir for 12 weeks (may be extended up to 96 weeks) Part 5: Additional groups of patients with chronic hepatitis B will receive ALG-000184 with entecavir for 12 weeks (may be extended up to 96 weeks)
Participants will:
Take study medication orally as directed Visit the clinic regularly for blood tests, physical examinations, and other safety assessments Have their HBV viral markers measured to determine if the treatment is working
Read the detailed description
ALG-000184-201 is a Phase 1, double-blind, randomized, placebo-controlled study evaluating ALG-000184, a novel capsid assembly modulator (CAM) targeting hepatitis B virus (HBV).
ALG-000184 is a prodrug that is converted to ALG-001075, a Class E CAM that inhibits HBV replication through two mechanisms: (1) blocking pregenomic RNA encapsidation, and (2) preventing the formation and transcription of covalently closed circular DNA (cccDNA).
The study employs a sequential approach, beginning with single-ascending dose (SAD) and multiple-ascending dose (MAD) evaluations in healthy volunteers, then progressing to monotherapy assessments in chronic hepatitis B (CHB) subjects, and finally testing combination therapy with entecavir.
A Study Review Committee (SRC) oversees safety throughout the trial and determines dose escalation based on predefined criteria. Each cohort in Parts 1-3 includes a 4:1 (ALG-000184:placebo) randomization ratio, while Parts 4-5 include extended treatment durations to evaluate longer-term efficacy and safety.
The study includes comprehensive pharmacokinetic assessments and extensive virologic evaluations (HBV DNA, HBV RNA, HBsAg, HBeAg, HBcrAg, and resistance monitoring). An ALT Flare Committee specifically reviews and manages liver-related safety events.
Part 4 focuses on HBeAg-positive subjects to explore potential HBsAg declines, as the secondary mechanism of action of ALG-000184 may be more pronounced in subjects with higher cccDNA levels. The trial includes provisions for extending treatment duration up to 96 weeks based on emerging safety and efficacy data.
- Conditions
- Chronic Hepatitis B
- Being tested
- ALG-000184, Placebo, Entecavir
- 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.
ALG-000184Drug
Single or multiple doses of ALG-000184
PlaceboDrug
Single or multiple doses of Placebo
EntecavirDrug
multiple doses of Entecavir
| Study group | Role | What they receive |
|---|---|---|
| ALG-000184 | Experimental | Oral tablet(s) of ALG-000184 in HV or CHB subjects once daily for up to 96 weeks Receives: Drug: ALG-000184 |
| Placebo | Placebo comparator | Oral tablet(s) of placebo in HV or CHB subjects once daily for up to 12 weeks Receives: Drug: Placebo |
| Entecavir in combination with ALG-000184 | Active comparator | Oral tablet(s) of ALG-000184 in combination with Entecavir in CHB subjects once or twice daily for up to 96 weeks Receives: Drug: ALG-000184; Drug: Entecavir |
| Placebo plus Entecavir | Active comparator | Oral tablet(s) of matching placebo in combination with Entecavir in CHB subjects once daily for 12 weeks, with option to switch to open-label ALG-000184 plus Entecavir for up to 96 weeks (Part 4). Receives: Drug: ALG-000184; Drug: Entecavir |
| Open-label ALG-000184 plus Entecavir | Experimental | Open-label oral tablet(s) of ALG-000184 in combination with Entecavir in CHB subjects once daily for up to 96 weeks (Part 5) Receives: Drug: Placebo; Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 8 days for Part 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 21 days for Part 2
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 112 days for Part 3
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 of ALG-184 in combination with Entecavir (Parts 4 and 5)
Measured: Up to 756 days for parts 4 & 5
Secondary outcomes (6)
Maximum Plasma Concentration [Cmax]
Pharmacokinetic parameters of ALG-000184 in plasma
Measured: Predose up to763 Days
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-000184 in plasma
Measured: Predose up to 763 Days
Time to maximum plasma concentration [Tmax]
pharmacokinetic parameters of ALG-000184 in plasma
Measured: Predose up to 763 Days
Half-time [t1/2]
Pharmacokinetic parameters of ALG-000184 in plasma
Measured: Predose up to 763 Days
Minimum Plasma Concentration [Cmin]
Pharmacokinetic parameters of ALG-000184 in plasma
Measured: Predose up to 763 Days
Change in HBV DNA from baseline through Day 812 in Multiple Dose HBV Infected Patients
Measured: Screening up to Day 812
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start22 Oct 2020
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Model description
- This is a parallel-group study with several parts. In Parts 1-3, participants are randomized in a 4:1 ratio to receive either ALG-000184 or matching placebo. In Part 4, participants are randomized in a 4:1 ratio to receive either ALG-000184 plus entecavir or placebo plus entecavir. In Part 5, all participants receive open-label ALG-000184 plus entecavir. The study follows a dose-escalation design where doses are increased across cohorts based on safety and pharmacokinetic data from previous cohorts. Each participant remains in their assigned treatment group throughout their participation in the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 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
- NCT04536337
- Sponsor's protocol ID
- ALG-000184-201
- Status last verified
- Nov 2025
- First submitted
- 28 Aug 2020
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yuen MF, Agarwal K, Jucov A, Hou J, Niu J, Ding Y, Haceatrean A, Liang X, Xu J, Wu M, Le K, Lin TI, Blatt L, Chanda S, Fry J, Gane E. ALG-000184 (pevifoscorvir sodium) monotherapy in participants with chronic HBV infection: a phase 1, multicentre, randomised, dose escalation trial. Lancet Gastroenterol Hepatol. 2026 Mar;11(3):218-231. doi: 10.1016/S2468-1253(25)00293-6. Epub 2026 Jan 16.
PubMed 41554267Gane E, Schwabe C, Wu M, Lin TI, Blatt L, Fry J, Chanda S, Le K. A Phase 1 study of the safety, tolerability, and pharmacokinetics of ALG-000184 (pevifoscorvir sodium), a novel Class E capsid assembly modulator, in healthy participants. Antivir Ther. 2025 Dec;30(6):13596535251392955. doi: 10.1177/13596535251392955. Epub 2025 Nov 21.
PubMed 41268712Li C, Wu M, Zhang H, Mai J, Yang L, Ding Y, Niu J, Mao J, Wu W, Zhang D, Tang Y, Yan W. Safety, Tolerability, and Pharmacokinetics of the Novel Hepatitis B Virus Capsid Assembly Modulator GST-HG141 in Healthy Chinese Subjects: a First-in-Human Single- and Multiple-Dose Escalation Trial. Antimicrob Agents Chemother. 2021 Sep 17;65(10):e0122021. doi: 10.1128/AAC.01220-21. Epub 2021 Jul 19.
PubMed 34280012
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Orally Administered ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single-Ascending Doses (Part 1) and Multiple-Ascending Doses in Healthy Volunteers (Part 2), and Multiple Doses in Subjects With Chronic Hepatitis B (Part 3)
- ClinicalTrials.gov ID
- NCT04536337
- Acronym / sponsor ID
- ALG-000184-201
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Aligos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 2 Sep 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.
The goal of this clinical trial is to learn if ALG-000184 is safe, well-tolerated, and works to treat chronic hepatitis B virus (HBV) infection. The main questions it aims to answer are:
Is ALG-000184 safe and well-tolerated when given alone or with entecavir (a standard HBV treatment)? Does ALG-000184 reduce HBV viral levels in the blood of patients with chronic hepatitis B? How does the body process ALG-000184 (pharmacokinetics)?
Researchers will compare ALG-000184 to placebo (a look-alike substance that contains no drug) to see if ALG-000184 works better at reducing hepatitis B viral markers.
The study has five parts:
Parts 1 and 2: Healthy volunteers will receive single or multiple doses of ALG-000184 or placebo Part 3: Patients with chronic hepatitis B will receive ALG-000184 or placebo daily for 28 days Part 4: Patients with chronic hepatitis B will receive ALG-000184 or placebo combined with entecavir for 12 weeks (may be extended up to 96 weeks) Part 5: Additional groups of patients with chronic hepatitis B will receive ALG-000184 with entecavir for 12 weeks (may be extended up to 96 weeks)
Participants will:
Take study medication orally as directed Visit the clinic regularly for blood tests, physical examinations, and other safety assessments Have their HBV viral markers measured to determine if the treatment is working
Detailed description
ALG-000184-201 is a Phase 1, double-blind, randomized, placebo-controlled study evaluating ALG-000184, a novel capsid assembly modulator (CAM) targeting hepatitis B virus (HBV).
ALG-000184 is a prodrug that is converted to ALG-001075, a Class E CAM that inhibits HBV replication through two mechanisms: (1) blocking pregenomic RNA encapsidation, and (2) preventing the formation and transcription of covalently closed circular DNA (cccDNA).
The study employs a sequential approach, beginning with single-ascending dose (SAD) and multiple-ascending dose (MAD) evaluations in healthy volunteers, then progressing to monotherapy assessments in chronic hepatitis B (CHB) subjects, and finally testing combination therapy with entecavir.
A Study Review Committee (SRC) oversees safety throughout the trial and determines dose escalation based on predefined criteria. Each cohort in Parts 1-3 includes a 4:1 (ALG-000184:placebo) randomization ratio, while Parts 4-5 include extended treatment durations to evaluate longer-term efficacy and safety.
The study includes comprehensive pharmacokinetic assessments and extensive virologic evaluations (HBV DNA, HBV RNA, HBsAg, HBeAg, HBcrAg, and resistance monitoring). An ALT Flare Committee specifically reviews and manages liver-related safety events.
Part 4 focuses on HBeAg-positive subjects to explore potential HBsAg declines, as the secondary mechanism of action of ALG-000184 may be more pronounced in subjects with higher cccDNA levels. The trial includes provisions for extending treatment duration up to 96 weeks based on emerging safety and efficacy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- This is a parallel-group study with several parts. In Parts 1-3, participants are randomized in a 4:1 ratio to receive either ALG-000184 or matching placebo. In Part 4, participants are randomized in a 4:1 ratio to receive either ALG-000184 plus entecavir or placebo plus entecavir. In Part 5, all participants receive open-label ALG-000184 plus entecavir. The study follows a dose-escalation design where doses are increased across cohorts based on safety and pharmacokinetic data from previous cohorts. Each participant remains in their assigned treatment group throughout their participation in the study.
| Arm | Type | Receives |
|---|---|---|
| ALG-000184 | Experimental | Drug: ALG-000184Oral tablet(s) of ALG-000184 in HV or CHB subjects once daily for up to 96 weeks |
| Placebo | Placebo comparator | Drug: PlaceboOral tablet(s) of placebo in HV or CHB subjects once daily for up to 12 weeks |
| Entecavir in combination with ALG-000184 | Active comparator | Drug: ALG-000184, Drug: EntecavirOral tablet(s) of ALG-000184 in combination with Entecavir in CHB subjects once or twice daily for up to 96 weeks |
| Placebo plus Entecavir | Active comparator | Drug: ALG-000184, Drug: EntecavirOral tablet(s) of matching placebo in combination with Entecavir in CHB subjects once daily for 12 weeks, with option to switch to open-label ALG-000184 plus Entecavir for up to 96 weeks (Part 4). |
| Open-label ALG-000184 plus Entecavir | Experimental | Drug: Placebo, Drug: EntecavirOpen-label oral tablet(s) of ALG-000184 in combination with Entecavir in CHB subjects once daily for up to 96 weeks (Part 5) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Female subjects must have a negative serum pregnancy test at screening
- Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria
- In addition to inclusion criteria 1-2, the following inclusion criteria also apply to HV's (Parts 1 and 2)
- Male or female between 18 and 55 years of age, extremes included.
- Subjects must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 32.0 kg/m2, extremes included.
Key exclusion criteria (17 listed)
- Subjects with any previous or current 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 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 of clinical evidence at screening of significant or unstable cardiac disease etc.
- Subjects with a history of clinically significant drug allergy
- Subject with a current history of clinically significant (as determined by investigator) skin disease requiring intermittent or chronic treatment
- Excessive use of alcohol, defined as regular consumption of ≥14 standard drinks/week for women and ≥21 standard drinks/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 |
|---|---|---|
| ALG-000184Single or multiple doses of ALG-000184 | Drug | ALG-000184, Entecavir in combination with ALG-000184, Placebo plus Entecavir |
| PlaceboSingle or multiple doses of Placebo | Drug | Open-label ALG-000184 plus Entecavir, Placebo |
| Entecavirmultiple doses of Entecavir | Drug | Entecavir in combination with ALG-000184, Open-label ALG-000184 plus Entecavir, Placebo plus Entecavir |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: up to 8 days for Part 1
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: up to 21 days for Part 2
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: up to 112 days for Part 3
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 756 days for parts 4 & 5
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 of ALG-184 in combination with Entecavir (Parts 4 and 5)
6 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: Predose up to763 Days
Area under the concentration time curve [AUC]
Time frame: Predose up to 763 Days
Time to maximum plasma concentration [Tmax]
Time frame: Predose up to 763 Days
Half-time [t1/2]
Time frame: Predose up to 763 Days
Minimum Plasma Concentration [Cmin]
Time frame: Predose up to 763 Days
Change in HBV DNA from baseline through Day 812 in Multiple Dose HBV Infected Patients
Time frame: Screening up to Day 812
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 Nov 2025.
- Derived from this study: PubMed 41554267Yuen MF, Agarwal K, Jucov A, Hou J, Niu J, Ding Y, Haceatrean A, Liang X, Xu J, Wu M, Le K, Lin TI, Blatt L, Chanda S, Fry J, Gane E. ALG-000184 (pevifoscorvir sodium) monotherapy in participants with chronic HBV infection: a phase 1, multicentre, randomised, dose escalation trial. Lancet Gastroenterol Hepatol. 2026 Mar;11(3):218-231. doi: 10.1016/S2468-1253(25)00293-6. Epub 2026 Jan 16.
- Derived from this study: PubMed 41268712Gane E, Schwabe C, Wu M, Lin TI, Blatt L, Fry J, Chanda S, Le K. A Phase 1 study of the safety, tolerability, and pharmacokinetics of ALG-000184 (pevifoscorvir sodium), a novel Class E capsid assembly modulator, in healthy participants. Antivir Ther. 2025 Dec;30(6):13596535251392955. doi: 10.1177/13596535251392955. Epub 2025 Nov 21.
- Derived from this study: PubMed 34280012Li C, Wu M, Zhang H, Mai J, Yang L, Ding Y, Niu J, Mao J, Wu W, Zhang D, Tang Y, Yan W. Safety, Tolerability, and Pharmacokinetics of the Novel Hepatitis B Virus Capsid Assembly Modulator GST-HG141 in Healthy Chinese Subjects: a First-in-Human Single- and Multiple-Dose Escalation Trial. Antimicrob Agents Chemother. 2021 Sep 17;65(10):e0122021. doi: 10.1128/AAC.01220-21. Epub 2021 Jul 19.
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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.
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALG-000184 and Entecavir in people with Chronic Hepatitis B, run by Aligos Therapeutics at 10 sites in 6 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 21 inclusion and 17 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 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, Australia, Hong Kong, Mauritius, Moldova and 1 more country. 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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: up to 8 days for Part 1). 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?
On the ClinicalTrials.gov record for NCT04536337, which also lists 3 linked publications.
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 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.