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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05001022
Other study ID # ALG-020572-401
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date September 25, 2021
Est. completion date July 18, 2022

Study information

Verified date April 2023
Source Aligos Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Randomized Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date July 18, 2022
Est. primary completion date July 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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. BMI 18.0 to 32.0 kg/m^2 4. Subjects must have a 12-lead ECG that meets protocol criteria Inclusion Criteria for CHB Subjects: 1. Male and Female between 18 and 75 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. For virally suppressed subjects, must be currently receiving HBV NA treatment for =6 months prior to screening. For currently not treated or treatment naïve subjects, must have never received treatment OR have not been on treatment within 6 months prior to randomization 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 antibodies 12. Subjects with liver fibrosis that is classified as Metavir Score =F3

Study Design


Intervention

Drug:
ALG-020572
Single or multiple doses of ALG-020572
Placebo
Single or multiple doses of Placebo

Locations

Country Name City State
New Zealand Auckland Clinical Studies Auckland
United Kingdom King's College Hospital London
United Kingdom St George's University of London London

Sponsors (1)

Lead Sponsor Collaborator
Aligos Therapeutics

Countries where clinical trial is conducted

New Zealand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 up to 60 days for Part 1
Primary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 up to 120 days for Part 2
Secondary Maximum Plasma Concentration [Cmax] Pharmacokinetic parameters of ALG-020572 in plasma Predose (0 hours) up to 45 Days (1080 hours)
Secondary Area under the concentration time curve [AUC] Pharmacokinetic parameters of ALG-020572 in plasma Predose (0 hours) up to 45 Days (1080 hours)
Secondary Time to maximum plasma concentration [Tmax] Pharmacokinetic parameters of ALG-020572 in plasma Predose (0 hours) up to 45 Days (1080 hours)
Secondary Half-time [t1/2] Pharmacokinetic parameters of ALG-020572 in plasma Predose (0 hours) up to 45 Days (1080 hours)
Secondary Minimum Plasma Concentration [Cmin] Pharmacokinetic parameters of ALG-020572 in plasma Predose (0 hours) up to 45 Days (1080 hours)
Secondary Change in HBsAg (reduction) from baseline through Day 120 in Multiple Dose HBV Infected Patients Screening, Day 1, 2, 4, 8, 11, 15, 22, 29, 36, 45, 60, 90, 120
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