Chronic Hepatitis B
Conditions
Brief summary
A Randomized Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
Interventions
DRUGALG-010133
Single or multiple doses of ALG-010133
DRUGPlacebo
Single or multiple doses of Placebo
Sponsors
Aligos Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
for Healthy Subjects: 1. Male and Female between 18 and 55 years old 2. Female subjects must have a negative serum pregnancy test at screening 3. Subjects must be nonsmokers for at least 3 months prior to randomization 4. BMI 18.0 to 32.0 kg/m\^2 5. Subjects must have a 12-lead ECG that meets protocol criteria Inclusion Criteria for CHB Subjects: 1. Male and Female between 18 and 70 years old 2. Female subjects must have a negative serum pregnancy test at screening 3. BMI 18.0 to 35.0 kg/m\^2 4. HBeAg-negative chronic hepatitis B or HBeAg-positive chronic hepatitis B and are currently receiving HBV NA treatment for ≥6 months prior to screening 5. Subjects must have a 12-lead ECG that meets protocol criteria
Exclusion criteria
for Healthy Subjects: 1. 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 2. 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. 3. Subjects with a history of clinically significant drug allergy 4. Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment 5. Excessive use of alcohol defined as regular consumption of ≥14 units/week for women and ≥21 units/week for men 6. Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow up 7. Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection 8. Subjects with renal dysfunction (e.g., estimated creatinine clearance \<90 mL/min/1.73 m\^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | up to 15 days for Part 1 | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration time curve [AUC] | Predose (0 hours) up to 162 Days (3864 hours) | Pharmacokinetic parameters of ALG-010133 in plasma |
| Time to maximum plasma concentration [Tmax] | Predose (0 hours) up to 162 Days (3864 hours) | Pharmacokinetic parameters of ALG-010133 in plasma |
| Maximum Plasma Concentration [Cmax] | Predose (0 hours) up to 162 Days (3864 hours) | Pharmacokinetic parameters of ALG-010133 in plasma |
| Minimum Plasma Concentration [Cmin] | Predose (0 hours) up to 162 Days (3864 hours) | Pharmacokinetic parameters of ALG-010133 in plasma |
| Change in HBsAg (reduction) from baseline through Day 78 in Multiple Dose HBV Infected Patients | Screening, Day -1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 | — |
| Half-time [t1/2] | Predose (0 hours) up to 162 Days (3864 hours) | Pharmacokinetic parameters of ALG-010133 in plasma |
Countries
China, Hong Kong, Moldova, New Zealand, South Korea, United Kingdom
Outcome results
None listed