A Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

Aligos Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: ALG-010133; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04485663

ALG-010133-101

Details and patient eligibility

About

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

Enrollment: 103 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Exclusion Criteria for CHB 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. Subjects with Hepatitis A, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
7. 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)
8. 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)
9. Subjects must have absence of signs of hepatocellular carcinoma
10. Subjects with history or current liver cirrhosis
11. Subjects positive for anti-HBs anitbodies
12. Subjects with liver fibrosis that is classified as Metavir Score ≥F3

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 2 patient groups, including a placebo group

ALG-010133

Experimental group

Description:

Subcutaneous injections of ALG-010133 in HV or CHB subjects up to every 7 days for up to 12 weeks

Treatment:

Drug: ALG-010133

Placebo

Placebo Comparator group

Description:

Subcutaneous injections of placebo in HV or CHB subjects up to every 7 days for up to 12 weeks

Treatment:

Drug: Placebo