A Phase 1 interventional study of ALG-000184 and Placebo in Chronic Hepatitis B, sponsored by Aligos Therapeutics. Completed at 10 sites in 6 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Aligos Therapeutics · Phase 1, Interventional, and Treatment
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
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.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's enrollment of 165 is above the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Aligos Therapeutics is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for All Subjects:
Subjects must have a 12-lead (ECG) that meets the protocol criteria
Inclusion Criteria for Healthy Volunteers:
In addition to inclusion criteria 1-2, the following inclusion criteria also apply to HV's (Parts 1 and 2)
CHB Subjects:
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 medicine, or have never received treatment with 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 and AST must have ≤1.2× 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.
Exclusion Criteria
Exclusion Criteria for All Subjects:
Subjects with Hepatitis A, B, C, D, E or -1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
Exclusion Criteria for Healthy Volunteers (Parts 1 and 2):
In addition to exclusion criteria 1-6, the following exclusion criteria also apply to HV's (Parts 1 and 2)
Subjects with renal dysfunction (e.g., estimated \<90 mL/min/1.73 m2at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [] formula).
Exclusion Criteria for CHB Subjects (Parts 3, 4, and 5):
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral tablet(s) of ALG-000184 in HV or CHB subjects once daily for up to 96 weeks
Drug: ALG-000184
Oral tablet(s) of placebo in HV or CHB subjects once daily for up to 12 weeks
Drug: Placebo
Oral tablet(s) of ALG-000184 in combination with Entecavir in CHB subjects once or twice daily for up to 96 weeks
Drug: ALG-000184 · Drug: Entecavir
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).
Drug: ALG-000184 · Drug: Entecavir
Open-label oral tablet(s) of ALG-000184 in combination with Entecavir in CHB subjects once daily for up to 96 weeks (Part 5)
Drug: Placebo · Drug: Entecavir
Single or multiple doses of ALG-000184
Single or multiple doses of Placebo
multiple doses of Entecavir
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Up to 756 days for parts 4 & 5
Maximum Plasma Concentration [Cmax]
Pharmacokinetic parameters of ALG-000184 in plasma
Time frame: Predose up to763 Days
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-000184 in plasma
Time frame: Predose up to 763 Days
Time to maximum plasma concentration [Tmax]
pharmacokinetic parameters of ALG-000184 in plasma
Time frame: Predose up to 763 Days
Half-time [t1/2]
Pharmacokinetic parameters of ALG-000184 in plasma
Time frame: Predose up to 763 Days
Minimum Plasma Concentration [Cmin]
Pharmacokinetic parameters of ALG-000184 in plasma
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
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pevifoscorvir sodium · Entecavir
Aligos Therapeutics